Drug Information

View drug alerts Information in California, Georgia, or New York
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) for the treatment of individuals with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. Source: FDA website
New Indication 02-16-18
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (von Willebrand factor, recombinant, injection) for the treatment of perioperative management of bleeding in adults with von Willebrand disease. Source: FDA website
New Indication 04-17-18
Tagrisso
The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by a FDA-approved test. Source: FDA website
New Indication 04-18-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Source: FDA website
New Indication 04-16-18
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (fosnetupitant/palonosetron injection) for individuals with chemotherapy induced nausea and vomiting. Source: FDA website
New Formulation 04-20-18
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab-twza injection) for the treatment of X-linked hypophosphatemia (XLH) in adults and children 1 year of age and older. Source: FDA website
New Drug 04-17-18
Tavalisse
The Food and Drug Administration (FDA) approved TavalisseTM (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Source: FDA website
New Drug 04-17-18
Luzu
The Food and Drug Administration (FDA) approved Luzu® (luliconazole topical cream) for the treatment of tinea pedis, tinea cruris, and tinea corporis in individuals 12 years and older. Source: FDA website
New Indication 02-23-18
Verzenio
The Food and Drug Administration (FDA) approved Verzenio&tarde; (abemaciclib tablets) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer. Source: FDA website
New Indication 02-26-18
Otiprio
The Food and Drug Administration (FDA) approved Otiprio® (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months old and older due to Pseudomonas aeruginosa and Staphylococcus aureus. Source: FDA website
New Indication 03-02-18
Osmolex ER
The Food and Drug Administration (FDA) approved Osmolex ER™ (amantadine extended-release tablets) for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults. Source: FDA website
New Drug 02-19-18
Apadaz
The Food and Drug Administration (FDA) approved Apadaz™ (benzhydrocodone/acetaminophen tablets) for the short-term (14 or fewer days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Drug 02-23-18
ZTlido
The Food and Drug Administration (FDA) approved ZTlido&tarde; (lidocaine topical system) for the relief of pain associated with post-herpetic neuralgia (PHN). Source: FA website
New Drug 02-28-18
Cimduo
The Food and Drug Administration (FDA) approved Cimduo&tarde; (lamivudine/tenofovir disoproxil fumarate tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric individuals weighing at least 35 kg. Source: FDA website
New Drug 02-28-18
Biaxin
The Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic Biaxin®(clarithromycin) to individuals with heart disease due to a potential increased risk of heart problems or death that can occur years later. A new warning has been added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm Source: FDA website
Drug Warning 02-22-18
Clopidogrel
International Laboratories announced a voluntary recall of one lot of clopidogrel tablets 75 mg due to mislabeling. Contact your health care provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592047.htm Source: FDA website
Drug Recall 01-10-18
Dexycu
The Food and Drug Administration (FDA) approved Dexycu® (dexamethasone intraocular suspension injection) for the treatment of inflammation associated with cataract surgery. Source: FDA website
New Drug 02-12-18
Makena
The Food and Drug Administration (FDA) approved Makena® (hydroxyprogesterone caproate subcutaneous auto-injection) to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. Source: FDA website
New Formulation 02-14-18
Symdeko
The Food and Drug Administration (FDA) approved SymdekoTM (tezacaftor/ivacaftor) for the treatment of individuals with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. Source: FDA website
New Drug 02-12-18
Erleada
The Food and Drug Administration (FDA) approved ErleadaTM (apalutamide tablets) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Drug 02-14-18
Acyclovir
Apace Packaging announced a voluntary recall of one lot of acyclovir 400 mg tablets due to product mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596590.htm Source: FDA website
Drug Recall 02-14-18
Balcoltra
The Food and Drug Administration (FDA) approved BalcoltraTM (levonorgestrel/ethinyl estradiol/ferrous bisglycinate tablets) for the prevention of pregnancy. Source: FDA website
New Drug 01-17-18
Trisenox
The Food and Drug Administration (FDA) approved Trisenox® (arsenic trioxide injection) in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Source: FDA website
New Indication 01-15-18
Gilotrif
The Food and Drug Administration (FDA) approved Gilotrif® (afatinib tablets) in first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.Source: FDA website
New Indication 01-12-18
Fluarix Quadrivalent
The Food and Drug Administration (FDA) approved Fluarix® Quadrivalent (quadrivalent inactivated split virus influenza vaccine injection) to include use in individuals aged 6 months and older for active immunization against influenza A subtype viruses and type B viruses. Source: FDA website
New Indication 01-12-18
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the treatment of individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Source: FDA website
New Indication 01-12-18
Isentress
The Food and Drug Administration (FDA) approved Isentress® (raltegravir oral) to include treatment of human immunodeficiency virus (HIV) exposed full-term newborns who weigh at least 2 kg and are up to 4 weeks of age. Source: FDA website
New Indication 11-27-17
Auvi-Q
The Food and Drug Administration (FDA) approved Auvi-Q® (epinephrine 0.1 mg auto-injector) for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5-33 lbs. who are at risk for or have a history of serious allergic reactions. Source: FDA website
New Indication 11-20-17
Juluca
The Food and Drug Administration (FDA) approved Juluca® (dolutegravir/rilpivirine tablets) as treatment regimen for certain adults with human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 11-21-17
Clenpiq
The Food and Drug Administration (FDA) approved ClenpiqTM (sodium picosulfate/magnesium oxide/anhydrous citric acid ready-to-drink oral solution) for cleansing of the colon in adults undergoing a colonoscopy. Source: FDA website
New Drug 11-29-17
Sublocade
The Food and Drug Administration (FDA) approved SublocadeTM (buprenorphine extended-release monthly subcutaneous injection) for the treatment of moderate-to-severe opioid use disorder in adults who have initiated treatment with a transmucosal buprenorphine-containing product. Source: FDA website
New Drug 11-30-17
Limbrel
The Food and Drug Administration (FDA) is investigating serious adverse events involving Limbrel® (flavocoxid capsules) currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. Reports of adverse events include drug-induced liver injury and hypersensitivity pneumonitis which are potentially life-threatening. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm Source: FDA website
Drug Warning 11-21-17
Biotin
The Food and Drug Administration (FDA) is alerting health care providers and consumers that biotin (vitamin B7) can significantly interfere with certain lab tests. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm Source: FDA website
Drug Warning 11-28-17
Riomet
Sun Pharmaceuticals announced a recall of two lots of Riomet® (metformin oral solution) due to contamination with Scopulariopsis brevicaulis. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586510.htm Source: FDA website
Drug Recall 11-27-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for previously treated individuals with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1. Source: FDA website
New Indication 09-22-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of hepatocellular carcinoma previously treated with sorafenib. Source: FDA website
New Indication 09-22-17
Genvoya
The Food and Drug Administration (FDA) approved Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for use in children with human immunodeficiency virus (HIV) weighing at least 25 kg. Source: FDA website
New Indication 09-27-17
Fiasp
The Food and Drug Administration (FDA) approved Fiasp® (insulin aspart rapidly-acting injection) to improve glycemic control in adults with type 1 and type 2 diabetes. Source: FDA website
New Drug 09-29-17
Verzenio
The Food and Drug Administration (FDA) approved VerzenioTM (abemaciclib tablets) for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Source: FDA website
New Drug 09-28-17
Tracleer
The Food and Drug Administration (FDA) approved Tracleer® (bosentan tablets) for use in children 3 years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. Source: FDA website
New Indication 09-06-17
Durolane
The Food and Drug Administration (FDA) approved Durolane® (hyaluronic acid injection) for the treatment of pain associated with knee osteoarthritis. It is a single-injection therapy. Source: FDA website
New Drug 09-05-17
Mylotarg
The Food and Drug Administration (FDA) approved MylotargTM (gemtuzumab ozogamicin injection) for the treatment of CD33-positive acute myeloid leukemia (AML) in newly-diagnosed adults, and refractory or relapsed AML in adults and children 2 years of age and older. Source: FDA website
New Drug 09-01-17
Foshan Flying Medical Products
The Food and Drug Administration (FDA) is alerting healthcare providers and consumers not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products located in China due to a lack of sterility assurance and other quality issues. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574576.htm
Source: FDA website
Drug Warning 09-01-17
Victoza
The Food and Drug Administration (FDA) approved Victoza® (liraglutide injection) for the reduction of risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Source: FDA website
New Indication 08-25-17
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. Source: FDA website
New Indication 08-28-17
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab injection) for the treatment of chimeric antigen receptor T cell (CAR-T) therapy cell-induced severe or life-threatening cytokine release syndrome (CRS) in individuals 2 years of age and older. Source: FDA website
New Indication 08-30-17
Austedo
The Food and Drug Administration (FDA) approved AustedoTM (deutetrabenazine tablets) for the treatment of tardive dyskinesia in adults. Source: FDA website
New Indication 08-30-17
Duzallo
The Food and Drug Administration (FDA) approved Duzallo® (lesinurad/allopurinol tablets) for the treatment of hyperuricemia associated with gout in individuals who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. Source: FDA website
New Drug 08-21-17
Gocovri
The Food and Drug Administration (FDA) approved GocovriTM (amantadine extended-release capsules) for the treatment of dyskinesia in individuals with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Source: FDA website
New Drug 08-24-17
Vabomere
The Food and Drug Administration (FDA) approved VabomereTM (meropenem/vaborbactam injection) for adults with complicated urinary tract infections (cUTIs). Source: FDA website
New Drug 08-29-17
Benznidazole
The Food and Drug Administration (FDA) approved Benznidazole tablets for Chagas disease in children 2 to 12 years old. Source: FDA website
New Drug 08-29-17
KedRAB
The Food and Drug Administration (FDA) approved KedRABTM (rabies immunoglobulin human injection) for passive, transient post-exposure prophylaxis of rabies infection. Source: FDA website
New Drug 08-25-17
Kymriah
The Food and Drug Administration (FDA) approved KymriahTM (tisagenlecleucel injection) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in individuals up to 25 years old. Source: FDA website
New Drug 08-30-17
Ninjacof and Ninjacof A
Centurion Labs announced a voluntary recall of one lot of NinjacofTM (chlophedianol/pyrilamine maleate oral liquid) and one lot of NinjacofTM A (acetaminophen/ chlophedianol/pyrilamine maleate oral liquid) due to potential contamination with Burkholderia cepacia. These products are used to temporarily relieve symptoms due to the common cold, allergic rhinitis, or other respiratory allergies. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm572909.htm
Source: FDA website
Drug Recall 08-23-17
CaroSpir
The Food and Drug Administration (FDA) approved CaroSpir® (spironolactone oral suspension) for the treatment of heart failure and reduced ejection fraction. Source: FDA website
New Drug 08-07-17
QVAR RediHaler
The Food and Drug Administration (FDA) approved QVAR® RediHalerTM (beclomethasone dipropionate HFA inhalation aerosol) for the maintenance treatment of asthma as a prophylactic therapy in individuals 4 years of age and older Source: FDA website
New Drug 08-07-17
Nikita
The Food and Drug Administration (FDA) approved NikitaTM (pitavastatin tablets) for the treatment of primary hyperlipidemia and mixed dyslipidemia. Source: FDA website
New Drug 08-09-17
PharmaTech
The Food and Drug Administration (FDA) is advising healthcare providers and consumers not to use any liquid product manufactured by PharmaTech and distributed by Rugby Laboratories due to contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570674.htm Source: FDA website
Drug Warning 08-08-17
Vital Rx
The Food and Drug Administration (FDA) is advising healthcare providers and consumers not to use drug products intended to be sterile that are produced and distributed by Vital Rx, doing business as Atlantic Pharmacy and Compounding, Pompano Beach, Florida due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570944.htm Source: FDA website
Drug Warning 08-10-17
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Source: FDA website
New Indication 08-17-17
Besponsa
The Food and Drug Administration (FDA) approved Besponsa® (inotuzumab ozogamicin injection) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
New Drug 08-17-17
Pravastatin
International Laboratories announced a voluntary recall of one lot of pravastatin sodium 40 mg tablets due to mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571066.htm. Source: FDA website
Drug Recall 08-10-17
Lorazepam
Amneal Pharmaceuticals announced a voluntary recall of 13 lots of lorazepam oral concentrate 2 mg/mL due to misprinted dosing droppers. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571796.htm. Source: FDA website
Drug Recall 08-16-17
PharmaTech
The distribution firms Leader brand, Major Pharmaceuticals, and Rugby Laboratories announced a voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech at its facility in Davie, Fla due to possible product contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570997.htm. Source: FDA website
Drug Recall 08-10-17
Vectibix
The Food and Drug Administration (FDA) approved Vectibix® (panitumumab injection) for individuals with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Source: FDA website
New Indication 06-29-17
Orencia
The Food and Drug Administration (FDA) approved Orencia® (abatacept injection) for the treatment of active psoriatic arthritis (PsA) in adults. Source: FDA website
New Indication 07-06-17
Triptodur
The Food and Drug Administration (FDA) approved TriptodurTM (triptorelin injection) for the treatment of individuals 2 years of age and older with central precocious puberty (CPP). Dosing is once every 6 months. Source: FDA website
New Drug 06-30-17
Fibryna
The Food and Drug Administration (FDA) approved Fibryna® (fibrinogen, human, concentrate injection) for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Source: FDA website
New Drug 06-07-17
Endari
The Food and Drug Administration (FDA) approved EndariTM (L-glutamine oral powder) to reduce the acute complications of sickle cell disease in adult and pediatric individuals 5 years and older. Source: FDA website
New Drug 07-07-17
NovoPen Echo Insulin Delivery Device
Novo Nordisk announced a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm565955.htm Source: FDA website
Drug Recall 07-06-17
Zykadia
The Food and Drug Administration (FDA) approved Zykadia® (ceritinib capsules) for use in first-line anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Source: FDA website
New Indication 05-26-17
Zerviate
The Food and Drug Administration (FDA) approved ZerviateTM (cetirizine ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
New Drug 06-01-17
Isentress HD
The Food and Drug Administration (FDA) approved Isentress® HD (raltegravir tablets) for use in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals (weighing 40 kg or more) who are treatment-naive or whose virus has been suppressed on an initial regimen of Isentress 400 mg twice daily. Source: FDA website
New Drug 05-30-17
Rebinyn
The Food and Drug Administration (FDA) approved Rebinyn® (nonacog beta pegol injection) for the treatment of individuals with hemophilia B. Source: FDA website
New Drug 06-01-17
Mibela 24 FE
Lupin Pharmaceuticals announced a recall of one lot of Mibela 24 FE (norethindrone acetate/ethinyl estradiol chewable tablets and ferrous fumarate tablets) due to out of sequence tablets and missing expiration date and lot information. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560908.htm Source: FDA website
Drug Recall 05-29-17
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) for individuals with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Source: FDA website
New Indication 05-09-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with pemetrexed and carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. Source: FDA website
New Indication 05-10-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Source: FDA website
New Indication 05-18-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Source: FDA website
New Indication 05-18-17
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in individuals with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 05-18-17
Minolira
The Food and Drug Administration (FDA) approved MinoliraTM (minocycline extended-release tablets) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in individuals aged 12 years and older. Source: FDA website
New Drug 05-10-17
Canagliflozin
The Food and Drug Administration (FDA) has concluded that the type 2 diabetes medication canagliflozin (Invokana®, Invokamet®, and Invokamet® XR) causes an increased risk of leg and foot amputations. New warnings, including a Boxed Warning, will be added to canagliflozin drug labels. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm Source: FDA website
Drug Warning 05-16-17
Ilaris
TThe Food and Drug Administration (FDA) approved Ilaris® (canakinumab injection) for use in individuals with Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF). Source: FDA website
New Indication 09-23-16
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of moderately to severely active Crohn’s disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.Source: FDA website
New Indication 09-26-16
Orkambi
The Food and Drug Administration (FDA) approved Orkambi® (lumacaftor/ivacaftor tablets) for use in children with cystic fibrosis aged 6-11 years who have 2 copies of the F508del mutation. Source: FDA website
New Indication 09-28-16
Epaned
The Food and Drug Administration (FDA) approved Epaned® (enalapril maleate oral solution) for the treatment of hypertension in adults and children >1 month, to lower blood pressure. It is also indicated to treat symptomatic heart failure and asymptomatic left ventricular dysfunction. Source: FDA website
New Drug 09-23-16
Direct-Acting Antivirals for Hepatitis C
The Food and Drug Administration (FDA) is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any individual who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medications for hepatitis C virus. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm Source: FDA website
Drug Warning 10-04-16
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of adults with active ankylosing spondylitis (AS). Source: FDA website
New Indication 01-19-16
Arzerra
The Food and Drug Administration (FDA) approved Arzerra® (ofatumumab injection) for extended treatment of individuals who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 01-19-16
Kyprolis
The Food and Drug Administration (FDA) approved Kyprolis™ (carfilzomib injection) in combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of individuals with relapsed or refractory multiple myeloma who have received one to three lines of therapy. Source: FDA website
New Indication 01-21-16
Emverm
The Food and Drug Administration (FDA) approved Emverm™ (mebendazole chewable tablets) for treatment of pinworm (Enterobius vermicularis), whipworm (Trichuris trichiura), common roundworm (Ascaris lumbricoides), common hookworm (Ancylostoma duodenale), and American hookworm (Necator americanus), as single or mixed infections. Source: FDA website
New Drug 01-15-16
Humulin R U-500 KwikPen
The Food and Drug Administration (FDA) approved Humulin® R U-500 KwikPen® (human insulin pre-filled injection), a highly concentrated formulation of insulin providing insulin that is 5 times more concentrated than U-100 insulin products to treat high blood sugar in type 1 and 2 diabetes. Source: FDA website
New Drug 01-21-16
Abbott's Compounding Pharmacy
Abbott's Compounding Pharmacy announced a voluntary recall of all unexpired lots of sterile compounded products due to lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm482102.htm Source: FDA website
Drug Recall 01-16-16
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website
New Indication 01-19-16
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of lower limb spasticity in adults to decrease the severity of increased muscle stiffness in ankle and toe muscles. Source: FDA website
New Indication 01-22-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with Yervoy® (ipilimumab injection) for the treatment of individuals with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. Source: FDA website
New Indication 01-25-16
Halaven
The Food and Drug Administration (FDA) approved Halaven® (eribulin mesylate injection) for the treatment of unresectable or metastatic liposarcoma in individuals who have received prior chemotherapy containing an anthracycline. Source: FDA website
New Indication 01-28-16
Emend
The Food and Drug Administration (FDA) approved Emend® (fosaprepitant dimeglumine injection) for use in combination with other antiemetic agents to prevent delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). Source: FDA website
New Indication 02-04-16
Dexilant SoluTab
The Food and Drug Administration (FDA) approved Dexilant™ SoluTab (dexlansoprazole delayed-release orally disintegrating tablets) for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in individuals 18 years and older. Source: FDA website
New Drug 01-27-16
Adzenys XR-ODT
The Food and Drug Administration (FDA) approved Adzenys XR-ODT™ (amphetamine extended-release orally disintegrating tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years and older. Source: FDA website
New Drug 01-27-16
Onzetra Xsail
The Food and Drug Administration (FDA) approved Onzetra™ Xsail™ (sumatriptan nasal powder) for the treatment of migraine with or without aura in adults. Source: FDA website
New Drug 01-29-16
Zembrace SymTouch
The Food and Drug Administration (FDA) approved Zembrace™ SymTouch™ (sumatriptan succinate subcutaneous injection) for the treatment of acute migraine episodes with or without aura in adults who are inadequately managed with existing treatment regimens. Source: FDA website
New Drug 01-29-16
Zepatier
The Food and Drug Administration (FDA) approved Zepatier™ (elbasvir/grazoprevir tablets) for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections. Source: FDA website
New Drug 01-28-16
Daklinza
The Food and Drug Administration (FDA) approved Daklinza™ (daclatasvir tablets) for use in chronic hepatitis C virus (HCV) genotypes 1 and 3 with human immunodeficiency virus (HIV)-1 co-infection, advanced cirrhosis, and post-liver transplant recurrence of HCV. Source: FDA website
New Indication 02-05-16
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) in combination with ribavirin for 12 weeks for use in chronic hepatitis C virus (HCV) genotype 1- or 4- infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and for HCV genotype 1-infected individuals with decompensated cirrhosis (Child-Pugh B/C) including those who have undergone liver transplantation. Source: FDA website
New Indication 02-16-16
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Source: FDA website
New Indication 02-19-16
Gazyva
The Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab injection) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Source: FDA website
New Indication 02-26-16
Afinitor
The Food and Drug Administration (FDA) approved Afinitor® (everolimus tablets) for the treatment of adults with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Source: FDA website
New Indication 02-26-16
Sernivo
The Food and Drug Administration (FDA) approved Sernivo™ (betamethasone dipropionate topical spray) for the treatment of mild to moderate plaque psoriasis in individuals 18 years of age and older. Source: FDA website
New Drug 02-08-16
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib citrate extended-release tablets) for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in individuals who have had an inadequate response or intolerance to methotrexate (MTX). Source: FDA website
New Drug 02-24-16
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam oral solution and tablet and injection) as add-on therapy for the treatment of partial onset seizures in individuals 16 years of age and older. Source: FDA website
New Drug 02-19-16
Complera
The Food and Drug Administration (FDA) approved labeling for Complera® (emtricitabine/tenofovir disoproxil fumarate/rilpivirine tablets) to include expanded use in pediatric individuals aged 12 to less than 18 years old for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Indication 03-02-16
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) to include use in combination with palbociclib for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer whose cancer has progressed after endocrine therapy. Source: FDA website
New Indication 03-02-16
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) as a first-line treatment for individuals with chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 03-04-16
Xalkori
The Food and Drug Administration (FDA) approved Xalkori® (crizotinib capsules) for the treatment of metastatic non-small cell lung cancer (NSCLC) in individuals whose tumors are ROSI-1 positive. Source: FDA website
New Indication 03-11-16
Cetylev
The Food and Drug Administration (FDA) approved CetylevTM (acetylcysteine effervescent tablets for oral solution) as an antidote for acetaminophen overdose to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen. Source: FDA website
New Drug 01-29-16
Idelvion
The Food and Drug Administration (FDA) approved Idelvion® (albutrepenonacog alfa injection) for the on-demand control and prevention of bleeding episodes, management of postoperative bleeding, and as prophylaxis to reduce the frequency of bleeding episodes in hemophilia B in children and adults. Source: FDA website
New Drug 03-04-16
Odefsey
The Food and Drug Administration (FDA) approved Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 03-01-16
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate tablets) for pediatric individuals with human immunodeficiency virus (HIV)-1 weighing at least 17 kg. Source: FDA website
New Indication 03-14-16
Evomela
The Food and Drug Administration (FDA) approved Evomela™ (captisol-enabled melphalan injection) for the treatment of individuals with multiple myeloma. Specific labeling is for high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplant and palliative treatment for individuals for whom oral therapy is not appropriate. Captisol technology improves the stability of melphalan extending its use time to 5 hours, allowing for slower infusion rate, and for longer administration durations for pre-transplant chemotherapy. Source: FDA website
New Drug 03-14-16
Kovaltry
The Food and Drug Administration (FDA) approved Kovaltry® (antihemophilic factor VIII, recombinant injection) for the treatment of hemophilia A in adults and children. Source: FDA website
New Drug 03-17-16
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of adults with moderate-to-severe plaque psoriasis. Source: FDA website
New Drug 03-22-16
Cinqair
The Food and Drug Administration (FDA) approved Cinqair® (reslizumab injection) for the maintenance treatment of severe asthma in individuals 18 years and older with an eosinophilic phenotype. Source: FDA website
New Drug 03-23-16
Eye drops
The Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm490862.htm Source: FDA website
Drug Warning 03-15-16
Defitelio
The Food and Drug Administration (FDA) approved Defitelio® (defibrotide injection) for the treatment of adult and pediatric individuals with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). Source: FDA website
New Drug 03-03-16
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in patients 12 years of age and older, in combination with other antiretroviral agents. Source: FDA website
New Drug 04-04-16
Metformin-containing diabetes medications
The Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medications for diabetes to expand use in certain individuals with reduced kidney function. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494829.htm Source: FDA website
Drug Warning 04-08-16
Saxagliptin and alogliptin containing diabetes medications
The Food and Drug Administration (FDA) has found that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in individuals who already have heart or kidney disease. The FDA is adding new warnings to the drug labels. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm Source: FDA website
Drug Warning 04-05-16
Bromsite
The Food and Drug Administration (FDA) approved BromSite™ (bromfenac ophthalmic solution) for the treatment of inflammation and prevention of pain in individuals undergoing cataract surgery. Source: FDA website
New Drug 04-08-16
Venclexta
The Food and Drug Administration (FDA) approved Venclexta™ (venetoclax tablets) for the treatment of individuals with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Source: FDA website
New Drug 04-11-16
Gilotrif
The Food and Drug Administration (FDA) approved Gilotrif® (afatinib tablets) for the treatment of individuals with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. Source: FDA website
New Indication 04-15-16
G4 Platinum and G5 Mobile Continuous Glucose Monitoring receivers
Dexcom announced a voluntary recall of its Continuous Glucose Monitoring systems due to possible audible alarm failure. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495468.htm Source: FDA website
Drug Recall 04-11-16
Focus Diagnostics Laboratory examination kits
Focus Diagnostics announced a voluntary recall of Simplexa Herpes Simplex Virus 1 and 2 Direct and Simplexa Group A Strep Direct examination kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This could lead to inaccurate test results. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm496099.htm Source: FDA website
Drug Recall 04-14-16
Orfadin
The Food and Drug Administration (FDA) approved Orfadin® (nitisinone oral suspension) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Source: FDA website
New Drug 04-26-16
Xtampza ER
The Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone extended-release capsules) for the treatment of chronic pain. Source: FDA website
New Drug 04-26-16
Bevespi Aerosphere
The Food and Drug Administration (FDA) approved Bevespi Aerosphere™ (glycopyrrolate/formoterol fumarate oral inhalation aerosol) for the long-term, maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema. Source: FDA website
New Drug 04-25-16
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx™ (cabozantinib tablets) for the treatment of advanced renal cell carcinoma in individuals who have received prior anti-angiogenic therapy. Source: FDA website
New Drug 04-25-16
ProAir RespiClick
The Food and Drug Administration (FDA) approved ProAir RespiClick (albuterol sulfate oral inhalation powder) for the treatment or prevention of bronchospasm in children aged 4 to 11 years with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). Source: FDA website
New Indication 04-29-16
Viekira Pak
The Food and Drug Administration (FDA) approved Viekira Pak™ (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) without ribavirin in individuals with genotype 1b chronic hepatitis C virus (HCV) infection and compensated cirrhosis. Source: FDA website
New Indication 04-25-16
Nuplazid
The Food and Drug Administration (FDA) approved Nuplazid™ (pimavanserin tablets) for the treatment of psychosis associated with Parkinson's disease. Source: FDA website
New Drug 04-29-16
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel oral suspension) for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in individuals with epilepsy 12 years and older. Source: FDA website
New Drug 05-02-16
Akovaz
The Food and Drug Administration (FDA) approved Akovaz™ (ephedrine sulfate injection) for the management of hypotension in surgical settings. Source: FDA website
New Drug 04-29-16
Ameluz
The Food and Drug Administration (FDA) approved Ameluz® (aminolevulinic acid gel) for use in combination with photodynamic therapy for the treatment of actinic keratoses on the face and scalp. Source: FDA website
New Drug 05-10-16
Brintellix
The Food and Drug Administration (FDA) approved a brand name change for the antidepressant Brintellix® (vortioxetine tablets) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medication Brilinta® (ticagrelor tablets). The new brand name of the drug will be Trintellix®. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498607.htm Source: FDA website
Drug Warning 05-02-16
Aripiprazole
The Food and Drug Administration (FDA) is warning that impulse-control problems have been reported with the use of the antipsychotic drug aripiprazole. New warnings will be added to the drug labels for all aripiprazole-containing products. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm498823.htm Source: FDA website
Drug Warning 05-03-16
Olanzapine
The Food and Drug Administration (FDA) is warning that the antipsychotic drug olanzapine can cause a rare but serious skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). New warnings will be added to the drug labels for all olanzapine-containing products. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm Source: FDA website
Drug Warning 05-10-16
Fluoroquinolones
The Food and Drug Administration (FDA) is advising that the serious side effects associated with fluoroquinolone antibacterials generally outweigh the benefits for individuals with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For individuals with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm Source: FDA website
Drug Warning 05-12-16
Lenvima
The Food and Drug Administration (FDA) approved Lenvima® (lenvatinib capsules) in combination with everolimus for the treatment of individuals with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. Source: FDA website
New Indication 05-13-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Adcetris® (brentuximab vedotin injection). Source: FDA website
New Indication 05-17-16
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq™ (atezolizumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. Source: FDA website
New Drug 05-18-16
Nizoral
The Food and Drug Administration (FDA) is warning healthcare professionals to avoid prescribing the antifungal medication ketoconazole oral tablets for the unapproved uses of treating skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful drug interactions. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm502073.htm Source: FDA website
Drug Warning 05-19-16
Canagliflozin
The Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations in individuals treated with the diabetes medicine canagliflozin (Invokana®, Invokamet®). The agency will update the public when there is more information. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm Source: FDA website
Drug Warning 05-18-16
Invokamet
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) as a first-line treatment for adults with type 2 diabetes. Source: FDA website
New Indication 05-18-16
Fanapt
The Food and Drug Administration (FDA) approved Fanapt® (iloperidone tablets) as a maintenance treatment for adults with schizophrenia. Source: FDA website
New Indication 05-18-16
Teflaro
The Food and Drug Administration (FDA) approved Teflaro® (ceftaroline fosamil injection) in individuals aged 2 months to less than 18 years old with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcal pneumoniae and other designated susceptible bacteria.
New Indication 05-18-16
Crestor
The Food and Drug Administration (FDA) approved Crestor® (rosuvastatin tablets) for use in pediatric patients aged 7–17 years with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, nonHDL-C, and ApoB as adjunct to diet, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).
New Indication 05-18-16
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax Quadrivalent® (four-strain influenza vaccine injection) for influenza virus infection prevention in individuals 4 years of age and older. Source: FDA website
New Drug 05-18-16
Probuphine
The Food and Drug Administration (FDA) approved Probuphine® (buprenorphine implant for subdermal administration) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug 05-18-16
Ocaliva
The Food and Drug Administration (FDA) approved Ocaliva™ (obeticholic acid tablets) for the treatment of primary biliary cholangitis. Source: FDA website
New Drug 05-18-16
Afstyla
The Food and Drug Administration (FDA) approved Afstyla® (antihemophilic factor, recombinant, single chain injection) for the treatment of adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes. Source: FDA website
New Drug 05-18-16
Jentadueto XR
The Food and Drug Administration (FDA) approved Jentadueto® XR (linagliptin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin are appropriate. Source: FDA website
New Drug 05-18-16
Zinbryta
The Food and Drug Administration (FDA) approved Zinbryta™ (daclizumab injection) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website
New Drug 05-18-16
Byvalson
The Food and Drug Administration (FDA) approved Byvalson™ (nebivolol/valsartan tablets) for the treatment of hypertension to lower blood pressure. Source: FDA website
New Drug 06-06-16
Jetrea
The Food and Drug Administration (FDA) approved Jetrea® (ocriplasmin intravitreal injection) in an "already diluted" formulation for the treatment of symptomatic vitreomacular adhesion. Source: FDA website
New Drug 06-08-16
Loperamide
The Food and Drug Administration (FDA) is warning that taking higher than recommended doses of over-the-counter (OTC) and prescription diarrhea medicine loperamide, including through abuse or misuse of the product, can cause serious heart problems that can lead to death. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505303.htm Source: FDA website
Drug Warning 06-07-16
Nature Made
Pharmavite announced a voluntary recall on specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505761.htm Source: FDA website
Drug Warning 06-08-16
Over-the-Counter Antacid Products Containing Aspirin
The Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using over-the-counter (OTC) aspiring-containing antacids to treat heartburn, sour stomach, acid indigestion, or upset stomach. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505190.htm Source: FDA website
Drug Warning 06-06-16
Vaxchora
The Food and Drug Administration (FDA) approved Vaxchora™ (oral cholera vaccine) for the prevention of cholera caused by serogroup 01 for use in adults aged 18 through 64 years traveling to cholera-affected regions. Source: FDA website
New Drug 06-10-16
GoNitro
The Food and Drug Administration (FDA) approved GoNitro™ (nitroglycerin powder for sublingual use) to prevent angina pectoris. Source: FDA website
New Drug 06-13-16
Lansoprazole ODT
The Food and Drug Administration (FDA) approved Lansoprazole orally disintegrating tablets for the treatment of peptic ulcer. A trade name has not yet been determined. Source: FDA website
New Drug 06-07-16
Rayaldee
The Food and Drug Administration (FDA) approved Rayaldee® (calcifediol extended-release capsules) for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels <30 ng/mL. Source: FDA website
New Drug 06-17-16
Canagliflozin and Dapagliflozin
The Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin and dapagliflozin. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm Source: FDA website <30 ng/mL. Source: FDA website
Drug Warning 06-14-16
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of non-infectious intermediate, posterior, and panuveitis. Source: FDA website
New Indication 07-01-16
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) for an expanded age range to include children aged 6-11 years with moderate to severe persistent asthma with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids. Source: FDA website
New Indication 07-08-16
Prevnar
The Food and Drug Administration (FDA) approved Prevnar 13® (pneumococcal 13-valent conjugate vaccine injection) for an expanded age range to include adults 18 through 49 years of age for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes. Source: FDA website
New Indication 07-12-16
Dexilant and Dexilant SoluTab
The Food and Drug Administration (FDA) approved Dexilant® (dexlansoprazole delayed-release capsules and Dexilant® SoluTab (dexlansoprazole delayed-release orally-disintegrating tablets) for the treatment of gastroesophageal reflux disease (GERD) in individuals aged 12 to 17 years. Source: FDA website
New Indication 07-13-16
Syndros
The Food and Drug Administration (FDA) approved Syndros™ (dronabinol oral solution) for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in individuals who have failed to respond adequately to conventional antiemetic treatments. Source: FDA website
New Drug 07-05-16
Xiidra
The Food and Drug Administration (FDA) approved Xiidra™ (lifitegrast ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website
New Drug 07-12-16
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Source: FDA website
New Drug 06-28-16
Prezista
The Food and Drug Administration (FDA) approved Prezista® (darunavir tablets) for expanded use in pregnant women with human immunodeficiency virus (HV) infection. Source: FDA website
New Indication 07-18-16
Berinert
The Food and Drug Administration (FDA) approved Berinert® (C1 esterase inhibitor injection) for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in individuals < 12 years old. Source: FDA website
New Indication 07-18-16
Namzaric
The Food and Drug Administration (FDA) approved Namzaric™ (memantine/donepezil extended-release capsules) for expanded use allowing individuals with moderate to severe Alzheimer’s disease who are currently stabilized on donepezil 10 mg to start directly with Namzaric. New dosage strengths were also approved: 7 mg/10 mg and 21 mg/10 mg capsules. Source: FDA website
New Indication 07-19-16
Synjardy
The Food and Drug Administration (FDA) approved Synjardy® (empagliflozin/metformin tablets) for expanded use to include treatment naïve adults with type 2 diabetes. Source: FDA website
New Indication 07-19-16
Belviq XR
The Food and Drug Administration (FDA) approved Belviq XR® (lorcaserin extended-release tablets) for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of ≥30 kg/m2 (obese) or BMI of ≥27 kg/m2 (overweight) with at least one weight-related medical condition (e.g., high blood pressure, high cholesterol, type 2 diabetes). Source: FDA website
New Drug 07-19-16
Relistor
The Food and Drug Administration (FDA) approved Relistor® (methylnaltrexone bromide tablets) for the treatment of opioid-induced constipation for individuals with pain not caused by cancer. Source: FDA website
New Drug 07-19-16
Viekira XR
The Food and Drug Administration (FDA) approved Viekira XR® (dasabuvir/ombitasvir/paritaprevir and ritonavir extended-release tablets) for the once daily treatment of adults with chronic hepatitis C virus (HCV) genotype 1 infection. Source: FDA website
New Drug 07-22-16
Adlyxin
The Food and Drug Administration (FDA) approved Adlyxin™ (lixisenatide injection) for the once-daily treatment of adults with type 2 diabetes mellitus. Source: FDA website
New Drug 07-27-16
Human chorionic gonadotropin (HCG) and sermorelin
Talon Compounding Pharmacy (TCP) announced a voluntary recall of all unexpired lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP due to a lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm512729.htm Source: FDA website
Drug Recall 07-22-16
Fluoroquinolones
The Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (oral or injectable) with regards to disabling and potentially permanent adverse effects affecting the tendons, muscles, joints, nerves, and central nervous system. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm513065.htm Source: FDA website
Drug Warning 07-26-16
Qbrelis
The Food and Drug Administration (FDA) approved Qbrelis™ (lisinopril oral solution) for the treatment of hypertension in adults and pediatric individuals 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. Source: FDA website
New Drug 07-29-16
Sustol
The Food and Drug Administration (FDA) approved Sustol® (granisetron extended-release injection) for use with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Source: FDA website
New Drug 08-10-16
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of lower limb spasticity in individuals age 2 years and older. Source: FDA website
New Indication 08-01-16
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Source: FDA website
New Indication 08-05-16
PharmaTech liquid drug and dietary supplement products
PharmaTech announced a voluntary recall of all their liquid products due to a potential risk of product contamination with Burkholderia cepacia. Contact your healthcare professional with any questions. More details including affected products may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515625.htm Source: FDA website
Drug Recall 08-09-16
Arzerra
The Food and Drug Administration (FDA) approved Arzerra®(ofatumumab injection) for use in combination with fludarabine and cyclophosphamide for the treatment of individuals with relapsed chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 08-31-16
Troxyca ER
The Food and Drug Administration (FDA) approved Troxyca® ER (naltrexone/oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Source: FDA website
New Drug 08-19-16
Eye/wash/Eye irrigating solutions
United Exchange Corp. of Cerritos, CA announced a voluntary recall of Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash due to microbial contamination. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519570.htm Source: FDA website
Drug Recall 09-07-16
GlucaGen HypoKit (glucagon rDNA origin)
Novo Nordisk announced a voluntary recall of six batches of GlucaGen HypoKit due to customer complaints of detached needles on the syringe. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519907.htm Source: FDA website
Drug Recall 09-09-16
Lamotrigine
Impax Laboratories announced a voluntary recall of one lot of Lamotrigine orally disintegrating tablets 20 mg due to incorrect labeling of blister cards. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518486.htm Source: FDA website
Drug Recall 08-29-16
Opioid pain or cough medicines combined with benzodiazepines
The Food and Drug Administration (FDA) is requiring the addition of Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicine and benzodiazepines regarding serious risks of these medications. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm518710.htm Source: FDA website
Drug Warning 08-31-16
Cuvitru
The Food and Drug Administration (FDA) approved Cuvitru® (immune globulin, human 20% subcutaneous injection) for the treatment of primary immunodeficiency disorders in individuals 2 years and older. Source: FDA website
New Drug 09-14-16
Yosprala
The Food and Drug Administration (FDA) approved Yosprala™ (omeprazole/aspirin tablets) to treat individuals who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers. Source: FDA website
New Drug 09-15-16
Kyleena
The Food and Drug Administration (FDA) approved Kyleena™ (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 5 years. Source: FDA website
New Drug 09-19-16
Lomaira
The Food and Drug Administration (FDA) approved Lomaira™ (phentermine tablets) as a short-term (few weeks) adjunct in a regimen for weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in individuals with an initial body mass index > 30 kg/m2, or > 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Source: FDA website
New Drug 09-19-16
Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® XR (canagliflozin/metformin extended-release tablets) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. Source: FDA website
New Drug 09-21-16
Exondys 51
The Food and Drug Administration (FDA) approved Exondys 51™ (eteplirsen injection) for the treatment of Duchenne muscular dystrophy (DMD) in individuals with confirmed mutation of the DMD gene amenable to exon 51 skipping. Source: FDA website
New Drug 09-19-16
Wells Pharmacy Network
Wells Pharmacy Network announced a voluntary recall of all unexpired sterile products prepared between February 22, 2016 and September 14, 2016 due to concern over lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm522103.htm Source: FDA website
Drug Recall 09-22-16
Hyoscyamine sulfate
Virtus Pharmaceuticals announced a voluntary recall of seven lots of Hyoscyamine sulfate 0.125 mg tablets, sublingual tablets, and orally disintegrating tablets due to superpotent and subpotent test results. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm520868.htm Source: FDA website
Drug Recall 09-15-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Source: FDA website
New Indication 11-10-16
Vemlidy
The Food and Drug Administration (FDA) approved Vemlidy® (tenofovir alafenamide tablets) for the treatment of adults with hepatitis B virus (HBV) infection with compensated liver disease. Source: FDA website
New Drug 11-11-16
Bonjesta
The Food and Drug Administration (FDA) approved Bonjesta (doxylamine succinate/pyridoxine HCL extended-release tablets) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Source: FDA website
New Drug 11-11-16
Intrarosa
The Food and Drug Administration (FDA) approved Intrarosa™ (prasterone vaginal insert) for the treatment of women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Source: FDA website
New Drug 11-17-16
Essure Permanent Birth Control System
Essure labeling now includes the addition of a boxed warning regarding adverse outcomes and the potential need for removal. The labeling will also include a Patient Decision Checklist. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529241.htm Source: FDA website
Drug Warning 11-15-16
Xultophy
The Food and Drug Administration (FDA) approved Xultophy® (insulin degludec/liraglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. Source: FDA website
New Drug 11-21-16
Soliqua
The Food and Drug Administration (FDA) approved SoliquaTM (insulin glargine/lixisenatide injection for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide. Source: FDA website
New Drug 11-21-16
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for relapsed or refractory multiple myeloma. Source: FDA website
New Indication 11-21-16
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. Source: FDA website
New Indication 12-02-16
Belladonna Extract
Raritan Pharmaceuticals announced a voluntary recall of homeopathic products containing belladonna extract due to the potential for variation in the content of belladonna. Consult your healthcare provider with questions. More details including products affected may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm530642.htm Source: FDA website
Drug Recall 11-25-16
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) for individuals with platinum-sensitive recurrent ovarian cancer in combination with chemotherapy. Source: FDA website
New Indication 12-06-16
Tresiba
The Food and Drug Administration (FDA) approved Tresiba® (insulin degludec injection) for expanded use to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes. Source: FDA website
New Indication 12-19-16
Synjardy XR
The Food and Drug Administration (FDA) approved Synjardy® XR (empagliflozin/metformin extended-release tablets) as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken. Source: FDA website
New Drug 12-13-16
Eucrisa
The Food and Drug Administration (FDA) approved Eucrisa™ (crisaborole ointment) for the treatment of mild to moderate atopic dermatitis in individuals aged 2 years or older. Source: FDA website
New Drug 12-14-16
Rubraca
The Food and Drug Administration (FDA) approved Rubraca™ (rucaparib tablets) for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test. Source: FDA website
New Drug 12-19-16
General anesthetic and sedation drugs
The Food and Drug Administration (FDA) is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect development of children’s brains. The FDA is requiring warnings to be added to labels of general anesthetic and sedation drugs. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm Source: FDA website
Drug Warning 12-14-16
Adynovate
The Food and Drug Administration (FDA) approved Adynovate® (antihemophilic factor, recombinant, PEGylated injection) to treat hemophilia A in pediatric individuals 12 years and younger and for use in surgical settings for both pediatric and adult individuals. Source: FDA website
New Indication 12-27-16
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of individuals with myopic choroidal neovascularization (mCNV). Source: FDA website
New Indication 01-06-17
Arymo ER
The Food and Drug Administration (FDA) approved Arymo ™ ER (morphine sulfate extended-release tablets) for pain severe enough to require daily, around-the-clock, long-acting treatment for which other options are inadequate. Source: FDA website
New Drug 01-09-17
Spinraza
The Food and Drug Administration (FDA) approved Spinraza™ (nusinersen intrathecal injection) for the treatment of children and adults with spinal muscular atrophy (SMA). Source: FDA website
New Drug 12-23-16
Saphris
The Food and Drug Administration (FDA) approved Saphris® (asenapine tablets) for use as maintenance monotherapy treatment in adults with bipolar disorder. Source: FDA website
New Indication 01-18-17
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for the treatment of individuals with marginal zone lymphoma (MZL) who require systemic therapy and have received one or more prior anti-CD20-based therapy. Source: FDA website
New Indication 01-19-17
Vantrela ER
The Food and Drug Administration (FDA) approved Vantrela™ ER (hydrocodone bitartrate extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Source: FDA website
New Drug 01-18-17
Rhofade
The Food and Drug Administration (FDA) approved Rhofade™ (oxymetazoline topical cream) for the treatment of persistent facial erythema associated with rosacea in adults. Source: FDA website
New Drug 01-19-17
Trulance
The Food and Drug Administration (FDA) approved Trulance™ (plecanatide tablets) for the treatment of chronic idiopathic constipation (CIC) in adults. Source: FDA website
New Drug 01-19-17
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) for the treatment of schizophrenia in adolescents aged 13-17 years. Source: FDA website
New Indication 01-30-17
Symbicort
The Food and Drug Administration (FDA) approved Symbicort® (budesonide/formoterol fumarate dihydrate oral inhalation) for the treatment of asthma in pediatric individuals aged 6 to 12 years. Source: FDA website
New Indication 01-30-17
Stribild
The Food and Drug Administration (FDA) approved Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate tablets) for human immunodeficiency virus (HIV)-1 infection in pediatric individuals 12 years and older and weighing 35 kg or more. Source: FDA website
New Indication 01-31-17
Ofirmev
The Food and Drug Administration (FDA) approved Ofirmev® (acetaminophen injection) to include recommended dosing for treatment of fever in neonates (including premature neonates born 32 or more weeks gestational age) up to 28 days chronological age and for infants aged 29 days to 2 years. Source: FDA website
New Indication 02-01-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. Source: FDA website
New Indication 02-02-17
AirDuo RespiClick
The Food and Drug Administration (FDA) approved AirDuo™ RespiClick® (fluticasone propionate/salmeterol oral inhalation powder) for the treatment of asthma in individuals 12 years and older. Source: FDA website
New Drug 03-30-17
ArmonAir RespiClick
The Food and Drug Administration (FDA) approved ArmonAir™ RespiClick® (fluticasone propionate oral inhalation powder) as maintenance treatment of asthma as prophylactic therapy in individuals 12 years and older. Source: FDA website
New Drug 03-30-17
Chlorhexidine gluconate
The Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with skin antiseptic products containing chlorhexidine gluconate. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm539575.htm Source: FDA website
Drug Warning 02-02-17
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) as maintenance treatment for individuals with multiple myeloma following autologous hematopoietic stem cell transplant (Auto-HSCT). Source: FDA website
New Indication 02-22-17
Technivie
The Food and Drug Administration (FDA) approved Technivie™ (ombitasvir/paritaprevir/ritonavir tablets) for individuals with genotype 4 chronic hepatitis C infection (HCV) with compensated cirrhosis. Source: FDA website
New Indication 02-27-17
Qtern
The Food and Drug Administration (FDA) approved Qtern® (dapagliflozin/saxagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin 10 mg or who are already treated with dapagliflozin and saxagliptin. Source: FDA website
New Drug 02-28-17
Xermelo
The Food and Drug Administration (FDA) approved Xermelo™ (telotristat ethyl tablets) for the treatment of carcinoid syndrome diarrhea in combination with a somatostatin analog when symptoms are not adequately controlled with a somatostatin analog alone. Source: FDA website
New Drug 02-28-17
Odactra
The Food and Drug Administration (FDA) approved Odactra (house dust mite allergen extract sublingual tablets) for the treatment of house dust mite-induced allergic rhinitis in adults. Source: FDA website
New Drug 03-01-17
Edex
Endo Pharmaceuticals announced a recall of one lot of Edex® (alprostadil 10 mcg for injection) due to the potential lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm543526.htm Source: FDA website
Drug Recall 02-27-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for children and adults who have classical Hodgkin lymphoma (cHL) that has resisted treatment or relapsed after three or more prior lines of therapy. Source: FDA website
New Indication 03-14-17
Noctiva
The Food and Drug Administration (FDA) approved Noctiva™ (desmopressin acetate nasal spray) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least twice per night to void. Source: FDA website
New Drug 03-03-17
Nipride RTU
The Food and Drug Administration (FDA) approved Nipride RTU (sodium nitroprusside ready to use injection) for the immediate reduction of blood pressure. It is also approved for producing controlled hypotension to reduce bleeding during surgery and for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure peripheral vascular resistance and mean arterial blood pressure. Source: FDA website
New Drug 03-08-17
Symproic
The Food and Drug Administration (FDA) approved Symproic® (naldemedine tablets) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Source: FDA website
New Drug 03-23-17
Kisqali
The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) as initial endocrine-based treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer used with an aromatase inhibitor. Source: FDA website
New Drug 03-13-17
Xadago
The Food and Drug Administration (FDA) approved Xadago® (safinamide tablets) for the treatment of Parkinson's disease as add-on therapy to levodopa/carbidopa. Source: FDA website
New Drug 03-21-17
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) for treatment of adult and pediatric individuals 12 years and older with metastatic Merkel cell carcinoma (MCC). Source: FDA website
New Drug 03-23-17
Viberzi
The Food and Drug Administration (FDA) is warning that Viberzi® (eluxadoline tablets), a medication used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in individuals who do not have a gallbladder due to an increased risk of developing serious pancreatitis. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm Source: FDA website
Drug Warning 03-15-17
Qudexy XR
The Food and Drug Administration (FDA) approved Qudexy® XR (topiramate extended-release capsules) for use as prophylaxis of migraine headaches in adults and children aged 12 years and older. Source: FDA website
New Indication 03-30-17
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) labeling to include the addition of moderate to severe fingernail psoriasis data for individuals with moderate to severe chronic plaque psoriasis. Source: FDA website
New Indication 03-30-17
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
New Drug 03-28-17
Ocrevus
The Food and Drug Administration (FDA) approved Ocrevus™ (ocrelizumab injection) for the treatment of individuals with relapsing or primary progressive forms of multiple sclerosis. Source: FDA website
New Drug 03-28-17
Zejula
The Food and Drug Administration (FDA) approved Zejula™ (niraparib capsules) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Source: FDA website
New Drug 03-27-17
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for use with any aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Source: FDA website
New Indication 03-31-17
Austedo
The Food and Drug Administration (FDA) approved Austedo™ (deutetrabenazine tablets) for the treatment of chorea associated with Huntington's disease (HD). Source: FDA website
New Drug 04-03-17
EpiPen/EpiPen Jr
Mylan announced a voluntary recall of select lots of EpiPen® and EpiPen Jr® (epinephrine auto-injector) due to failure of device to activate. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550165.htm Source: FDA website
Drug Recall 03-31-17
Trokendi XR
The Food and Drug Administration (FDA) approved Trokendi XR® (topiramate extended-release capsules) for prophylaxis of migraine headache in individuals 12 years of age and older. Source: FDA website
New Indication 04-06-17
Sovaldi
The Food and Drug Administration (FDA) approved Sovaldi® (sofosbuvir tablets) to treat hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
New Indication 04-07-17
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) to treat hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
New Indication 04-07-17
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. Source: FDA website
New Indication 04-17-17
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) to treat diabetic retinopathy in individuals with or without diabetic macular edema (DME). Source: FDA website
New Indication 04-17-17
Ingrezza
The Food and Drug Administration (FDA) approved Ingrezza™ (valbenazine capsules) for the treatment of tardive dyskinesia in adults. Source: FDA website
New Drug 04-17-17
Homeopathic teething products
The Food and Drug Administration (FDA) announced a voluntary recall of all lots of Hyland’s Baby and Hyland’s Baby Nighttime teething tablets made by Standard Homeopathic Company due to confirmed levels of belladonna. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538687.htm Source: FDA website
Drug Recall 04-14-17
Phenobarbital
C.O. Truxton announced a voluntary recall of one lot of Phenobarbital 15 mg tablets due to a labeling error on declared strength. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554358.htm Source: FDA website
Drug Recall 04-21-17
Isomeric Pharmacy Solutions
Isomeric Pharmacy Solutions announced a voluntary recall of all lots of unexpired sterile products due to concerns of a lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm551299.htm Source: FDA website
Drug Recall 04-06-17
Thymoglobulin
The Food and Drug Administration (FDA) approved Thymoglobulin® (anti-thymocyte globulin, [rabbit] injection) for use with concomitant immunosuppression in the prophylaxis of acute rejection in individuals receiving a kidney transplant. Source: FDA website
New Indication 04-24-17
Stivarga
The Food and Drug Administration (FDA) approved Stivarga® (regorafenib tablets) for the treatment of individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 04-27-17
Xatmep
The Food and Drug Administration (FDA) approved Xatmep™ (methotrexate oral solution) for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric individuals. Source: FDA website
New Drug 04-26-17
RoxyBond
The Food and Drug Administration (FDA) approved RoxyBond™ (oxycodone tablets) for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Drug 04-26-17
Brineura
The Food and Drug Administration (FDA) approved Brineura™ (cerliponase alfa injection for intraventricular use) as a treatment to slow loss of ability to walk or crawl in symptomatic pediatric individuals 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Source: FDA website
New Drug 04-27-17
Rydapt
The Food and Drug Administration (FDA) approved Rydapt® (midostaurin capsules) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FMLT3 mutation-positive (FLT3+) as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Source: FDA website
New Drug 04-28-17
Illegal cancer treatments
The Food and Drug Administration (FDA) issued warning letters addressed to 14 U.S. based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554777.htm Source: FDA website
Drug Warning 04-25-17
Bunavail
The Food and Drug Administration (FDA) approved Bunavail® (buprenorphine/naloxone buccal film) for the induction of opioid addiction treatment. Source: FDA website
New Indication 05-02-17
Alunbrig
The Food and Drug Administration (FDA) approved Alunbrig™ (brigatinib tablets) for the treatment of individuals with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug 04-28-17
Tymlos
The Food and Drug Administration (FDA) approved Tymlos™ (abaloparatide subcutaneous injection) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or individuals who have failed or are intolerant to other available osteoporosis therapy. Source: FDA website
New Drug 04-28-17
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi™ (durvalumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or followng platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Source: FDA website
New Drug 05-01-17
Radicava
The Food and Drug Administration (FDA) approved Radicava™ (edaravone injection) to treat individuals with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. Source: FDA website
New Drug 05-05-17
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of lower limb spasticity in adults. Source: FDA website
New Indication 06-16-17
Norvir
The Food and Drug Administration (FDA) approved Norvir® (ritonavir oral powder) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in children and adults. Source: FDA website
New Drug 06-08-17
Symjepi
The Food and Drug Administration (FDA) approved Symjepi™ (epinephrine injection) for the emergency treatment of allergic reactions including anaphylaxis. Source: FDA website
New Drug 06-15-17
Topical products by Phillips Company
Phillips Company announced a voluntary recall of all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed due to concerns of manufacturing practices. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563204.htm Source: FDA website
Drug Recall 06-14-17
Paliperidone extended-release
Teva Pharmaceuticals announced a voluntary recall of one lot of paliperidone extended-release tablets 3 mg due to dissolution test failure. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563358.htm Source: FDA website
Drug Recall 06-15-17
Eliquis
Bristol-Myers Squibb announced a voluntary recall of one lot of Eliquis 5 mg tablets due to customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563035.htm Source: FDA website
Drug Recall 06-13-17
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for individuals with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 06-22-17
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with pomalidomide and dexamethasone for the treatment of individuals with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Source: FDA website
New Indication 06-16-17
Cotempla XR-ODT
The Food and Drug Administration (FDA) approved Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) for the once-daily treatment of children 6-17 years of age with attention-deficit/hyperactivity disorder (ADHD). Source: FDA website
New Drug 06-20-17
Mydayis
The Food and Drug Administration (FDA) approved Mydayis™ (amphetamine mixed salts capsules) as once-daily treatment for ADHD in individuals 13 years of age and older. Source: FDA website
New Drug 06-20-17
Rituxan Hycela
The Food and Drug Administration (FDA) approved Rituxan Hycela™ (rituximab/hyaluronidase injection) for adults with follicular lymphoma, diffuse B-cell lymphoma, and chronic lymphocytic leukemia. Source: FDA website
New Drug 06-22-17
Haegarda
The Food and Drug Administration (FDA) approved Haegarda® (C1 esterase inhibitor subcutaneous injection) for the prevention of hereditary angioedema (HAE) attacks in adolescents and adults. Source: FDA website
New Drug 06-22-17
Baxdela
The Food and Drug Administration (FDA) approved Baxdela™ (delafloxacin tablets and injection for intravenous use) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. Source: FDA website
New Drug 06-19-17
Bevyxxa
The Food and Drug Administration (FDA) approved Bevyxxa™ (betrixaban capsules) for the prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Source: FDA website
New Drug 06-23-17
Blincyto
The Food and Drug Administration (FDA) approved Blinctyo® (blinatumomab injection) for the treatment of individuals with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
New Indication 07-11-17
Zypitamag
The Food and Drug Administration (FDA) approved Zypitamag™ (pitavastatin tablets) for the treatment of primary or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). Source: FDA website
New Drug 07-18-17
Nerlynx
The Food and Drug Administration (FDA) approved Nerlynx™ (neratinib tablets) for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer, to follow trastuzumab-based therapy. Source: FDA website
New Drug 07-17-17
Vosevi
The Food and Drug Administration (FDA) approved Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir tablets) for the retreatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis who were previously treated with an NS5A inhibitor-containing regimen or in adults with genotype 1a or 3 who were previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. Source: FDA website
New Drug 07-18-17
Tremfya
The Food and Drug Administration (FDA) approved Tremfya™ (guselkumab injection) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 07-13-17
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets) as monotherapy use for the treatment of partial-onset seizures with or without secondarily generalized seizures in individuals with epilepsy 12 years of age and older. Source: FDA website
New Indication 07-27-17
Yervoy
The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) to include treatment of unresectable or metastatic melanoma in individuals 12 years of age and older. Source: FDA website
New Indication 07-24-17
Relizorb
The Food and Drug Administration (FDA) approved Relizorb® (immobilized lipase digestive enzyme cartridge) for use in individuals 5 years of age and older with fat malabsorption. Source: FDA website
New Indication 07-20-17
Abilify Maintena
The Food and Drug Administration (FDA) approved Abilify Maintena® (aripiprazole extended-release injectable suspension) for the maintenance monotherapy treatment of bipolar I disorder in adults. Source: FDA website
New Indication 07-28-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 08-01-17
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in individuals with cystic fibrosis (CF) who are 2 years of age and older and have 1 of 5 residual function mutations that results in a splicing defect in the CF transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 08-01-17
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. Source: FDA website
New Indication 08-02-17
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) for the treatment of hepatitis C genotypes 1 through 6 in individuals coinfected with human immunodeficiency virus (HIV). Source: FDA website
New Indication 08-02-17
Benlysta
The Food and Drug Administration (FDA) approved Benlysta® (belimumab subcutaneous injection) for the treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Source: FDA website
New Drug 07-21-17
Nityr
The Food and Drug Administration (FDA) approved Nityr™ (nitisinone tablets) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Source: FDA website
New Drug 08-01-17
Vyxeos
The Food and Drug Administration (FDA) approved Vyxeos™ (daunorubicin/cytarabine injection) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Source: FDA website
New Drug 08-03-17
Idhifa
The Food and Drug Administration (FDA) approved Idhifa® (enasidenib tablets) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Source: FDA website
New Drug 08-01-17
Mavyret
The Food and Drug Administration (FDA) approved Mavyret™ (glecaprevir/pibrentasvir tablets) for the treatment of individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adults with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Source: FDA website
New Drug 08-03-17
Guardian Pharmacy Services
The Food and Drug Administration (FDA) received reports of adverse events in individuals who were administered intravitreal injections of a drug containing triamcinolone and moxifloxacin compounded by Guardian Pharmacy Services in Dallas, Texas. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm569123.htm Source: FDA website
Drug Warning 07-28-17
Diocto
Rugby Laboratories announced a voluntary recall of Diocto docusate sodium liquid and syrup solutions) manufactured by PharmaTech due to possible product contamination. Contact your healthcare professional with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570014.htm Source: FDA website
Drug Recall 08-03-17
Symbicort
The Food and Drug Administration (FDA) approved Symbicort® (budesonide/formoterol fumarate dihydrate 160/4.5 mcg oral inhalation) to reduce exacerbations of chronic obstructive pulmonary disease (COPD). Source: FDA website
New Indication 09-14-17
Aptiom
The Food and Drug Administration (FDA) approved Aptiom® (eslicarbazepine acetate tablets) to include the treatment of partial-onset seizures in children and adolescents aged 4-17 years. Source: FDA website
New Indication 09-14-17
Afluria Quadrivalent
The Food and Drug Administration (FDA) approved Afluria® Quadrivalent (influenza vaccine injection) for use in individuals 5 years and older for influenza immunization. Source: FDA website
New Indication 09-14-17
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets, oral solution, and injection) as monotherapy for partial-onset (focal) seizures in individuals 16 years and older with epilepsy. Source: FDA website
New Indication 09-15-17
Aliqopa
The Food and Drug Administration (FDA) approved Aliqopa™ (copanlisib injection) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments. Source: FDA website
New Drug 09-14-17
Medtronic diabetes infusion sets
Medtronic announced a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps due to a vent membrane that may be susceptible to being blocked by fluid. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575778.htm Source: FDA website
Drug Recall 09-12-17
Privigen
The Food and Drug Administration (FDA) approved Privigen® (immune globulin intravenous, human, 10% liquid) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. Source: FDA website
New Indication 09-15-17
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) for the treatment of carcinoid syndrome to reduce the frequency of short-acting somatostatin analog rescue therapy. Source: FDA website
New Indication 09-18-17
Rapivab
The Food and Drug Administration (FDA) approved Rapivab™ (peramivir injection) for use in pediatric individuals 2 years and older with acute uncomplicated influenza who have been symptomatic for no more than 2 days. Source: FDA website
New Indication 09-21-17
Adzenys ER
The Food and Drug Administration (FDA) approved Adzenys ER™ (amphetamine extended-release oral suspension) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
New Drug 09-18-17
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol oral inhalation) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in individuals receiving Breo® Ellipta® (fluticasone furoate/vilanterol) who need additional treatment or individuals receiving Incruse® Ellipta® (umeclidinium) and Breo Ellipta. Source: FDA website
New Drug 09-18-17
Xhance
The Food and Drug Administration (FDA) approved Xhance™ (fluticasone propionate nasal spray) for the treatment of nasal polyps in adults. Xhance uses a new delivery device. Source: FDA website
New Drug 09-19-17
Solosec
The Food and Drug Administration (FDA) approved Solosec™ (secnidazole oral granules) for the single-dose treatment of bacterial vaginosis in adult women. Source: FDA website
New Drug 09-18-17
Botox Cosmetic
The Food and Drug Administration (FDA) approved Botox® Cosmetic (onabotulinumtoxinA injection) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. Source: FDA website
New Indication 10-03-17
Ascor
The Food and Drug Administration (FDA) approved Ascor® (ascorbic acid injection) for the short-term (up to 1 week) treatment of scurvy in adults and children ages 5 months and older for whom oral administration is not possible, insufficient, or contraindicated. Source: FDA website
New Drug 10-04-17
Zilretta
The Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis (OA) knee pain. Source: FDA website
New Drug 10-06-17
Lyrica CR
The Food and Drug Administration (FDA) approved Lyrica® CR (pregabalin extended-release tablets) for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. Source: FDA website
New Drug 10-12-17
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of adolescents aged 12 and over with moderate to severe plaque psoriasis. Source: FDA website
New Indication 10-16-17
Simponi Aria
The Food and Drug Administration (FDA) approved Simponi Aria® (golimumab injection) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. Source: FDA website
New Indication 10-20-17
Soliris
The Food and Drug Administration (FDA) approved Soliris® (eculizumab injection) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. Source: FDA website
New Indication 10-23-17
Shingrix
The Food and Drug Administration (FDA) approved Shingrix (zoster vaccine recombinant, adjuvanted injection) for the prevention of shingles (herpes zoster) in adults aged 50 and older. Source: FDA website
New Drug 10-20-17
Bydureon Bcise
The Food and Drug Administration (FDA) approved Bydureon® BCise™ (exenatide extended-release autoinjector) to improve glycemic control in adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise. Source: FDA website
New Drug 10-23-17
Varubi
The Food and Drug Administration (FDA) approved Varubi® (rolapitant injection) for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including but not limited to, highly emetogenic chemotherapy. Source: FDA website
New Drug 10-25-17
Yescarta
The Food and Drug Administration (FDA) approved Yescarta™ (axicabtagene ciloleucel injection) for the treatment of individuals with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant. Source: FDA website
New Drug 10-18-17
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablets and injection) for the treatment of partial-onset seizures in pediatric individuals ages 4 and older. Source: FDA website
New Indication 11-06-17
Alecensa
The Food and Drug Administration (FDA) approved Alecensa® (alectinib capsules) as a first-line treatment for individuals with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 11-06-17
Auryxia
The Food and Drug Administration (FDA) approved Auryxia® (ferric citrate tablets) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) who are not on dialysis. Source: FDA website
New Indication 11-07-17
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Source: FDA website
New Indication 11-09-17
Zelboraf
The Food and Drug Administration (FDA) approved Zelboraf® (vemurafenib tablets) for the treatment of adults with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. Source: FDA website
New Indication 11-06-17
Vyzulta
The Food and Drug Administration (FDA) approved Vyzulta™ (latanoprostene bunod ophthalmic solution) for the reduction of intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Drug 11-02-17
Prevymis
The Food and Drug Administration (FDA) approved Prevymis™ (letermovir tablets and injection) for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Source: FDA website
New Drug 11-08-17
Calquence
The Food and Drug Administration (FDA) approved Calquence® (acalabrutinib capsules) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Source: FDA website
New Drug 10-31-17
Sprycel
The Food and Drug Administration (FDA) approved Sprycel® (dasatinib tablets) to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Source: FDA website
New Indication 11-10-17
Vraylar
The Food and Drug Administration (FDA) approved Vraylar® (cariprazine capsules) for the maintenance treatment of adults with schizophrenia. Source: FDA website
New Indication 11-13-17
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) in combination with abemaciclib for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in women with disease progression after endocrine therapy. Source: FDA website
New Indication 11-15-17
Tekturna
The Food and Drug Administration (FDA) approved Tekturna® (aliskiren oral pellets) for the treatment of hypertension in adults and children 6 years of age and older. Source: FDA website
New Indication 11-15-17
Gazyva
The Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab injection) in combination with chemotherapy, followed by Gazyva monotherapy in responders, for individuals with previously untreated follicular lymphoma. Source: FDA website
New Indication 11-16-17
Sutent
The Food and Drug Administration (FDA) approved Sutent® (sunitinib malate capsules) for the adjuvant treatment of adults who are at a high risk of kidney cancer returning after a kidney has been removed. Source: FDA website
New Indication 11-16-17
Cinvanti
The Food and Drug Administration (FDA) approved Cinvanti™ (aprepitant injection) in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin and for nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Source: FDA website
New Drug 11-10-17
Heplisav
The Food and Drug Administration (FDA) approved Heplisav-B™ (hepatitis B vaccine injection) for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Source: FDA website
New Drug 11-10-17
Abilify MyCIte
The Food and Drug Administration (FDA) approved Abilify MyCite® (aripiprazole tablets with sensor) for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It has an ingestible sensor embedded in the tablet that records that the medication was taken. Source: FDA website
New Drug 11-14-17
Fasenra
The Food and Drug Administration (FDA) approved Fasenra™ (benralizumab injection) for the add-on maintenance treatment of severe eosinophilic asthma in patients at least 12 years old. Source: FDA website
New Drug 11-14-17
Mepsevii
The Food and Drug Administration (FDA) approved Mepsevii™ (vestronidase alfa injection) for the treatment of adults and children with mucopolysaccharidosis VII (MPS VII). Source: FDA website
New Drug 11-15-17
Hemlibra
The Food and Drug Administration (FDA) approved Hemlibra® (emicizumab-kxwh injection) to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A who have developed antibodies called Factor VIII inhibitors. Source: FDA website
New Drug 11-16-17
Uloric
The Food and Drug Administration (FDA) announced preliminary results from a safety clinical trial showing an increased risk of heart-related death with Uloric® (febuxostat) compared to another gout medication called allopurinol. Once final results are received, the FDA will conduct a review and update the public with new information. Contact your healthcare provider with any questions. More details are available at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm585281.htm Source: FDA website
Drug Warning 11-15-17
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). Source: FDA website
New Indication 12-12-17
Xeljanz; Xeljanz XR
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) and Xeljanz XR® (tofacitinib extended-release tablets) to treat adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Source: FDA website
New Indication 12-15-17
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for previously untreated advanced renal cell carcinoma. Source: FDA website
New Indication 12-19-17
Bosulif
The Food and Drug Administration (FDA) approved Bosulif® (bosutinib tablets) for the treatment of adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia. Source: FDA website
New Indication 12-19-17
Xepi
The Food and Drug Administration (FDA) approved Xepi™ (ozenoxacin topical cream) for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adults and children 2 months of age and older. Source: FDA website
New Drug 12-13-17
Eskata
The Food and Drug Administration (FDA) approved Eskata™ (hydrogen peroxide 40% topical solution) for the treatment of raised seborrheic keratoses. Source: FDA website
New Drug 12-15-17
Prexxartan
The Food and Drug Administration (FDA) approved Prexxartan® (valsartan oral solution) for the treatment of hypertension in adults and children 6 years and older, the treatment of heart failure, and to reduce the risk of cardiovascular death in clinically stable individuals with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets. Source: FDA website
New Drug 12-19-17
Rhopressa
The Food and Drug Administration (FDA) approved Rhopressa® (netarsudil ophthalmic solution) to reduce intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension. Source: FDA website
New Drug 12-18-17
Luxturna
"The Food and Drug Administration (FDA) approved Luxturna® (voretigene neparvovec subretinal injection) for the treatment of individuals with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Source: FDA website"
New Drug 12-19-17
Gadolinium-based contrast agents
The Food and Drug Administration (FDA) is requiring a class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) regarding gadolinium remaining in in the body for months to years after receiving these drugs. The FDA has concluded that the benefit of all approved GBCAs outweighs any potential risks; however is requiring these safety actions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm Source: FDA website
Drug Warning 12-19-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the adjuvant treatment of individuals with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Source: FDA website
New Indication 12-20-17
Perjeta
The Food and Drug Administration (FDA) approved Perjeta® (pertuzumab injection) in combination with Herceptin® (trastuzumab injection) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. Source: FDA website
New Indication 12-20-17
Procysbi
The Food and Drug Administration (FDA) approved Procysbi® (cysteamine bitartrate delayed-release capsules) to include children one year and older for the treatment of nephropathic cystinosis. Source: FDA website
New Indication 12-27-17
Xgeva (denosumab)
The Food and Drug Administration (FDA) approved Xgeva® (denosumab injection) for the prevention of skeletal-related events in individuals with multiple myeloma. Source: FDA website
New Indication 01-05-18
Siklos
The Food and Drug Administration (FDA) approved Siklos (hydroxyurea tablets) to reduce the frequency of painful crises and the need for blood transfusions in pediatric individuals 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website
New Drug 12-21-17
Steglatro
The Food and Drug Administration (FDA) approved Steglatro™ (ertugliflozin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM). Source: FDA website
New Drug 12-21-17
Steglujan
The Food and Drug Administration (FDA) approved Steglujan™ (ertugliflozin/sitagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Source: FDA website
New Drug 12-21-17
Segluromet
The Food and Drug Administration (FDA) approved Segluromet™ (ertugliflozin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. Source: FDA website
New Drug 12-21-17
Trulance
The Food and Drug Administration (FDA) approved Trulance® (plecanatide tablets) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Source: FDA website
New Indication 01-25-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton™ (somatropin injection) for the replacement of growth hormone (GH) in adults with GH deficiency. Source: FDA website
New Indication 02-01-18
Avycaz
The Food and Drug Administration (FDA) approved Avycaz® (ceftazidime/avibactam injection) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in patients aged 18 years and older caused by susceptible Gram-negative microorganisms. Source: FDA website
New Indication 02-01-18
Firvanq
The Food and Drug Administration (FDA) approved Firvanq™ (vancomycin oral solution) for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Source: FDA website
New Drug 01-29-18
Lutathera
The Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate injection), a radiopharmaceutical, for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) affecting the foregut, midgut, and hindgut. Source: FDA website
New Drug 01-26-18
Gericare Eye Wash
Kareway announced a voluntary recall of 60,000 lots of Gericare Eye Wash sterile eye irrigation solution due to the potential for product contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm595090.htm Source: FDA website
Drug Recall 02-02-18
Senna Laxative
Magno-Humphries Laboratories announced a recall of one lot of Basic Drugs brand of senna laxative tablets 8.6 mg due to mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm593201.htm Source: FDA website
Drug Recall 01-23-18
Imodium
The Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package for Imodium® (loperamide) over-the-counter (OTC) anti-diarrhea drug. The goal is to encourage safe use. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594403.htm Source: FDA website
Drug Warning 01-30-18
Feraheme
The Food and Drug Administration (FDA) approved Feraheme® (ferumoxytol injection) expanded use to include all eligible adults with iron deficiency anemia who have intolerance to oral iron or have had unsatisfactory response to oral iron. Source: FDA website
New Indication 02-05-18
Zytiga
The Food and Drug Administration (FDA) approved Zytiga® (abiraterone acetate tablets) for use in combination with prednisone for the treatment of individuals with metastatic high-risk castration-sensitive prostate cancer (CSPC). Source: FDA website
New Indication 02-08-18
HyperRAB
The Food and Drug Administration (FDA) approved HyperRAB® (rabies immune globulin injection) for rabies post-exposure prophylaxis. This new formulation has a higher potency than existing product. Source: FDA website
New Drug 02-06-18
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults who are treatment naïve or experienced. Source: FDA website
New Drug 02-07-18
Symfi Lo
The Food and Drug Administration (FDA) approved Symfi Lo™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals weighing 35 kg or greater. Source: FDA website
New Drug 02-05-18
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) for the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric individuals aged 10 to 17 years. Source: FDA website
New Indication 03-07-18
Hizentra
The Food and Drug Administration (FDA) approved Hizentra® (immune globulin, human, 20% subcutaneous injection) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. Source: FDA website
New Indication 03-16-18
Trogarzo
The Food and Drug Administration (FDA) approved Trogarzo™ (ibalizumab-uiyk injection for intravenous use) for combination treatment of human immunodeficiency virus (HIV-1) infection in heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Source: FDA website
New Drug 03-06-18
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) in combination with chemotherapy in adults with previously untreated Stage III or IV classical Hodgkin lymphoma. Source: FDA website
New Indication 03-20-18
Tasigna
The Food and Drug Administration (FDA) approved Tasigna® (nilotinib capsules) for use in first and second line pediatric individuals 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Source: FDA website
New Indication 03-22-18
Toujeo Max SoloStar
The Food and Drug Administration (FDA) approved Toujeo® Max SoloStar® (insulin glargine 300 Units/mL) to improve glycemic control in adults with diabetes mellitus. Source: FDA website
New Formulation 03-27-18
Ilumya
The Food and Drug Administration (FDA) approved Ilumya™ (tildrakizumab-asmn injection) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 03-21-18
Alka-Seltzer Plus Products
Bayer announced a voluntary recall of selected Alka-Seltzer Plus® packages due to ingredients on front sticker possibly not matching product in carton. Please contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm601463.htm Source: FDA website
Drug Recall 03-16-18
Blincyto
The Food and Drug Administration (FDA) approved Blincyto® (blinatumomab injection) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD), Source: FDA website
New Indication 03-29-18
Leukine
The Food and Drug Administration (FDA) approved Leukine® (sargramostim injection) to increase survival in children and adults exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome (H-ARS). Source: FDA website
New Indication 03-30-18
Bydureon
The Food and Drug Administration (FDA) approved Bydureon® (exenatide extended-release injection) as an add-on to basal insulin in adults with type 2 diabetes who have inadequate glycemic control. Source: FDA website
New Indication 04-03-18
Rubraca
The Food and Drug Administration (FDA) approved Rubraca® (rucaparib tablets) as maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Source: FDA website
New Indication 04-06-18
Afinitor Disperz
The Food and Drug Administration (FDA) approved Afinitor Disperz® (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric individuals 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Source: FDA website
New Indication 04-10-18
Symfi (efavirenz/lamivudine/tenofovir disoproxil fumarate)
The Food and Drug Administration (FDA) approved Symfi™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in adults and children weighing 40 kg or more. Symfi contains the same ingredients found in Symfi Lo but with a 600 mg dose of efavirenz versus 400 mg seen in Symfi Lo. Source: FDA website
New Formulation 03-28-18
Essure
The Food and Drug Administration (FDA) restricted sales of the Essure® permanent birth control system to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement". New labeling was also approved. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604126.htm Source: FDA website
Drug Warning 04-09-18
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy Ellipta for long-term, once-daily, maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 04-24-18
Jynarque
The Food and Drug Administration (FDA) approved Jynarque™ (tolvaptan tablets) to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Source: FDA website
New Drug 04-23-18
Lamictal
The Food and Drug Administration (FDA) warns that Lamictal® (lamotrigine) for seizures and bipolar disorder may cause a severe immune system reaction. A new warning will be added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm Source: FDA website
Drug Warning 04-25-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the adjuvant treatment of individuals with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Source: FDA website
New Indication 04-30-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the treatment of anaplastic thyroid cancer (ATC) that is BRAF V600E mutation positive and either cannot be surgically excised or is metastatic. Source: FDA website
New Indication 05-04-18
Myrbetriq
The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) in combination with solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Source: FDA website
New Indication 04-30-18
Kymriah
The Food and Drug Administration (FDA) approved Kymriah™ (tisagenlecleucel injection) for the treatment of adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Source: FDA website
New Indication 05-01-18
Andexxa
The Food and Drug Administration (FDA) approved Andexxa® (coagulation factor Xa [recombinant] inactivated-zhzo) to reverse the anticoagulation effects of factor Xa inhibitors when needed due to life-threatening or uncontrolled bleeding. Source: FDA website
New Drug 05-04-18
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules and oral solution) as adjunctive therapy for the treatment of partial onset seizures in individuals as young as 4 years old. Source: FDA website
New Indication 05-07-18
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination Velcade (bortezomib), melphalan, and prednisone for the treatment of individuals with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Source: FDA website
New Indication 05-07-18
Gilenya
The Food and Drug Administration (FDA) approved Gilenya® (fingolimod capsules) for the treatment of children and adolescents with relapsing multiple sclerosis (MS) who are aged 10 years or older. Source: FDA website
New Indication 05-11-18
Plenvu
The Food and Drug Administration (FDA) approved Plenvu® (polyethylene glycol 3350/sodium ascorbate/sodium sulfate/ascorbic acid/sodium chloride/potassium chloride for oral solution) for cleansing of the colon in preparation for colonoscopy in adults. Source: FDA website
New Drug 05-07-18
Medline Remedy Essentials No-Rinse Cleansing Foam
The Food and Drug Administration (FDA) is advising healthcare providers and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam due to a multistate outbreak of infection caused by Burkholderia cepacia. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607371.htm Source: FDA website
Drug Warning 05-10-18
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets and oral solution) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures in individuals 4 years of age and older. Source: FDA website
New Indication 05-14-18
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in individuals aged 2 years and older, as monotherapy or in combination with methotrexate. Source: FDA website
New Indication 05-14-18
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate tablets) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus (HIV)-1 infection in at-risk adolescents. Source: FDA website
New Indication 05-15-18
Lucemyra
The Food and Drug Administration (FDA) approved Lucemyra™ (lofexidine tablets) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Source: FDA website
New Drug 05-16-18
Aimovig
The Food and Drug Administration (FDA) approved Aimovig™ (erenumab subcutaneous injection) for the prevention of migraines in adults. Source: FDA website
New Drug 05-17-18
Lokelma
The Food and Drug Administration (FDA) approved Lokelma™ (sodium zirconium cyclosilicate for oral suspension) for the treatment of adults with hyperkalemia. Source: FDA website
New Drug 05-18-18
Doptelet
The Food and Drug Administration (FDA) approved Doptelet® (avatrombopag tablets) for the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Source: FDA website
New Drug 05-21-18
Dolutegravir
Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm Source: FDA website
Drug Warning 05-18-18
MBI Distributing
MBI Distributing, Inc. announced a voluntary recall of all lots of unexpired homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir due to a lack of adequate controls during the manufacturing process. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608254.htm Source: FDA website
Drug Recall 05-21-18
Prolia
The Food and Drug Administration (FDA) approved Prolia® (denosumab injection) for the treatment of glucocorticoid-induced osteoporosis. Source: FDA website
New Indication 05-21-18
Arnuity Ellipta
The Food and Drug Administration (FDA) approved Arnuity® Ellipta® (fluticasone furoate oral inhalation) as once-daily asthma maintenance treatment for children as young as age 5 years. Source: FDA website
New Indication 05-22-18
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Indication 05-29-18
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) for the treatment of adults with moderately to severely active ulcerative colitis. Source: FDA website
New Indication 05-30-18
Yonsa
The Food and Drug Administration (FDA) approved Yonsa® (abiraterone acetate tablets) micronized formulation for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. Source: FDA website
New Drug 05-23-18
Imvexxy
The Food and Drug Administration (FDA) approved Imvexxy™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, or vaginal pain during sexual activity caused by vulvar and vaginal atrophy during menopause. Source: FDA website
New Drug 05-30-18
Consensi
The Food and Drug Administration (FDA) approved Consensi™ (amlodipine/celecoxib tablets) for individuals for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Source: FDA website
New Drug 05-31-18
Palynziq
The Food and Drug Administration (FDA) approved Palynziq™ (pegvaliase-pqpz) to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations >600 micromol/L on existing management. Source: FDA website
New Drug 05-29-18
Olumiant
The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more tumor-necrosis factor (TNF) antagonists. Source: FDA website
New Drug 06-01-18
Benzocaine
The Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral products containing benzocaine should not be used to treat infants and children younger than 2 years. They are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label due to the risk of serious and potentially fatal blood disorder. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608612.htm Source: FDA website
Drug Warning 05-23-18
Ethyl alcohol
Lake Michigan Distilling Company, doing business as Ethanol Extraction, announced a recall of its 95% Ethyl alcohol product due to possible contamination with methanol. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608695.htm Source: FDA website
Drug Recall 05-24-18
Fluticasone propionate
Apotex announced a recall of fluticasone propionate nasal spray 50 mcg per spray due to the potential for small glass particles. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609488.htm Source: FDA website
Drug Recall 05-31-18
Taytulla
Allergan announced a recall of Taytulla™ (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules) due to out of sequence capsules. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609064.htm Source: FDA website
Drug Recall 05-29-18
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) in combination with carboplatin and Keytruda® (pembrolizumab injection) for the initial treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Source: FDA website
New Indication 06-05-18
Mircera
The Food and Drug Administration (FDA) approved Mircera® (methoxy polyethylene glycol-epoetin beta injection) for the treatment of pediatric individuals 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. Source: FDA website
New Indication 06-07-18
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) for the treatment of moderate to severe pemphigus vulgaris. Source: FDA website
New Indication 06-08-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Source: FDA website
New Indication 06-12-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of adult and pediatric individuals with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after two or more prior lines of therapy. Source: FDA website
New Indication 06-13-18
Venclexta
The Food and Drug Administration (FDA) approved Venclexta™ (venetoclax tablets) in combination with rituximab for the treatment of individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Source: FDA website
New Indication 06-08-18
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Source: FDA website
New Indication 06-13-18
Moxidectin
The Food and Drug Administration (FDA) approved Moxidectin tablets for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in individuals ages 12 years and older. Source: FDA website
New Drug 06-14-18
Guardian Pharmacy Services
At least 43 individuals reported adverse events after receiving eye injections of Guardian's Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. Adverse events reported included vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm610835.htm Source: FDA website
Drug Warning 06-14-18
Cinryze
The Food and Drug Administration (FDA) approved Cinryze® (C1 esterase inhibitor, human, injection) for the prevention of attacks in pediatric hereditary angioedema in individuals as young as 6 years. Source: FDA website
New Indication 06-21-18
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of excessive drooling in adults. Source: FDA website
New Indication 07-05-18
Nocdurna
The Food and Drug Administration (FDA) approved Nocdurna® (desmopressin acetate sublingual tablet) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Source: FDA website
New Formulation 06-22-18
Qbrexza
The Food and Drug Administration (FDA) approved Qbrexza™ (glycopyrronium topical cloths) for the treatment of primary axillary hyperhidrosis in individuals ages 9 years and older. Source: FDA website
New Formulation 06-29-18
Aristada Initio
The Food and Drug Administration (FDA) approved Aristada Initio™ (aripiprazole lauroxil extended-release injectable suspension) in combination with oral aripiprazole for the initiation of Aristada in the treatment of adults with schizophrenia. Aristada Initio is not for repeated dosing. Source: FDA website
New Formulation 07-02-18
Epidiolex
The Food and Drug Administration (FDA) approved Epidiolex® (cannabidiol oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in individuals 2 years of age and older. Source: FDA website
New Drug 06-25-18
Zemdri
The Food and Drug Administration (FDA) approved Zemdri™ (plazomicin injection) for adults with complicated urinary tract infections including pyelonephritis, caused by certain Enterobacteriaceae in individuals who have limited or no alternative treatment options. Source: FDA website
New Drug 06-26-18
Braftovi and Mektovi
The Food and Drug Administration (FDA) approved Braftovi® (encorafenib) and Mektovi™ (binimetinib) in combination for individuals with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Source: FDA website
New Drug 06-27-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy (ipilimumab injection)® for the treatment of adult and pediatric individuals 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 07-11-18
Intelence
The Food and Drug Administration (FDA) approved Intelence® (etravirine tablets) for treatment-experienced pediatric individuals 2 to <6 years of age weighing 10 kg or more for the treatment of human immunodeficiency virus (HIV)-1 infection, in combination with other antiretrovirals. Source: FDA website
New Indication 07-18-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton® (somatropin for subcutaneous injection) for the treatment of pediatric individuals with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2–4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. Source: FDA website
New Indication 07-19-18
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Indication 07-16-18
Kisqali
The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Source: FDA website
New Indication 07-18-18
Perseris
The Food and Drug Administration (FDA) approved Perseris™ (risperidone extended-release subcutaneous injection) for once-monthly treatment of schizophrenia in adults. Source: FDA website
New Formulation 07-27-18
Symtuza
The Food and Drug Administration (FDA) approved Symtuza™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for the treatment of adults with human immunodeficiency virus (HIV)-1 infection who are treatment-naïve or virologically suppressed on a stable antiretroviral regimen for 6 or more months with no known darunavir or tenofovir resistance substitutions. Source: FDA website
New Drug 07-18-18
Orilissa
The Food and Drug Administration (FDA) approved Orilissa™ (elagolix tablets) for the management of moderate to severe endometriosis-associated pain. Source: FDA website
New Drug 07-24-18
Krintafel
The Food and Drug Administration (FDA) approved Krintafel™ (tafenoquine tablets) for the prevention of relapse of Plasmodium vivax malaria in individuals aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. Source: FDA website
New Drug 07-23-18
TPOXX
The Food and Drug Administration (FDA) approved TPOXX® (tecovirimat capsules) for the treatment of human smallpox disease in adults and pediatric individuals weighing at least 13 kg. Source: FDA website
New Drug 07-16-18
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation as detected by an FDA approved test. Source: FDA website
New Drug 07-20-18
Fluoroquinolone antibiotics
The Food and Drug Administration (FDA) is strengthening current warnings in the prescribing label that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm Source: FDA website
Drug Warning 07-10-18
Ranier's Compounding Laboratory
The Food and Drug Administration (FDA) is alerting health care providers and consumers not to use drug products intended to be sterile that are produced and distributed by Ranier's Compounding Laboratory due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm612911.htm Source: FDA website
Drug Recall 07-10-18
Valsartan containing product
The Food and Drug Administration (FDA) announced a recall on valsartan products containing an impurity, N-nitrosodimethylamine (NDMA), a potentially cancer-causing substance. Contact your healthcare provider with any questions. More details including affected products may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm614030.htm Source: FDA website
Drug Recall 07-19-18
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) to include use in children aged at least 12 months but younger than 24 months who carry at least one responsive CFTR mutation. Source: FDA website
New Indication 08-15-18
Lenvima
The Food and Drug Administration (FDA) approved Lenvima® (lenvatinib capsules) for first-line treatment of individuals with unresectable hepatocellular carcinoma. Source: FDA website
New Indication 08-16-18
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy. Source: FDA website
New Indication 08-16-18
Cequa
The Food and Drug Administration (FDA) approved Cequa™ (cyclosporine ophthalmic solution) to increase tear production in individuals with keratoconjunctivitis sicca (dry eye). Source: FDA website
New Drug 08-16-18
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets and capsules) for combination use with rituximab for the treatment of adults with Waldenström's macroglobulinemia (WM). Source: FDA website
New Indication 08-27-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 08-20-18
Altreno
The Food and Drug Administration (FDA) approved Altreno™ (tretinoin lotion) for the treatment of acne vulgaris in individuals 9 years of age and older. Source: FDA website
New Formulation 08-24-18
Inveltys
The Food and Drug Administration (FDA) approved Inveltys™ (loteprednol etabonate ophthalmic suspension) for the treatment of post-operative inflammation and pain following ocular surgery. Source: FDA website
New Drug 08-23-18
Oxervate
The Food and Drug Administration (FDA) approved Oxervate™ (cenegermin ophthalmic solution) for the treatment of neurotrophic keratitis. Source: FDA website
New Drug 08-22-18
Takhzyro
The Food and Drug Administration (FDA) approved Takhzyro™ (lanadelumab-flyo injection) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in individuals 12 years and older. Source: FDA website
New Drug 08-23-18
Diacomit
The Food and Drug Administration (FDA) approved Diacomit® (stiripentol oral capsules and powder) for the treatment of seizures associated with Dravet syndrome in individuals 2 years of age and older taking clobazam. Source: FDA website
New Drug 08-23-18
Xerava
The Food and Drug Administration (FDA) approved Xerava™ (eravacycline injection) for the treatment of complicated intra-abdominal infections in individuals 18 years of age and older. Source: FDA website
New Drug 08-27-18
Torrent Pharmaceuticals
Torrent Pharmaceuticals Limited announced a voluntary recall of all lots of valsartan/amlodipine/HCTZ and valsartan tablets due to the detection of trace amounts of an unexpected impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617821.htm Source: FDA website
Drug Recall 08-21-18
King Bio
King Bio announced a voluntary recall of its Kids and Infant products due to potential microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617945.htm Source: FDA website
Drug Recall 08-22-18
Jivi
The Food and Drug Administration (FDA) approved Jivi® (antihemophilic factor, recombinant, PEGylated-aucl injection) approved for the treatment of hemophilia A. Source: FDA website
New Drug 08-30-18
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro™ (doravirine tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no prior antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Delstrigo
The Food and Drug Administration (FDA) approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) as a complete regimen for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
The Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. A new warning about this risk will be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm618908.htm Source: FDA website
Drug Warning 08-29-18
Hydrochlorothiazide
Accord Healthcare announced a voluntary recall of one lot of hydrochlorothiazide tablets 12.5 mg due to a labeling mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618583.htm Source: FDA website
Drug Recall 08-28-18
Children's Advil
Pfizer announced a voluntary recall of one lot of Children's Advil® due to dosage cup mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618675.htm Source: FDA website
Drug Recall 08-28-18
Quest Manufacturing
Quest Manufacturing announced they are expanding their voluntary recall of CVS Health 12 Hour Sinus Relief Nasal Mist to include all lots of nasal products and baby oral gels within expiration that were manufactured at the company’s Florida facility due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618803.htm Source: FDA website
Drug Recall 08-29-18
Weight Away Remedy
Living Well Remedies announced a voluntary recall of one lot of Weight Away Remedy due to microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618669.htm Source: FDA website
Drug Recall 08-28-18
HelloLife
HelloLife, Inc. announced a voluntary recall of all lots within expiration of Neuroveen™, Respitrol™, Thyroveev™ and Compulsin™ due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618926.htm Source: FDA website
Drug Recall 08-31-18
Tiglutik
The Food and Drug Administration (FDA) approved Tiglutik™ (riluzole oral suspension) for the treatment of amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 09-06-18
Cassipa
The Food and Drug Administration (FDA) approved Cassipa (buprenorphine/naloxone sublingual film) for the maintenance treatment of opioid dependence. Source: FDA website
New Formulation 09-07-18
Montelukast sodium
The Food and Drug Administration (FDA) is warning about a voluntary recall of one lot of montelukast sodium tablets by Camber Pharmaceuticals due to incorrect drug in bottles. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619825.htm Source: FDA website
Drug Recall 08-31-18
Beaumont Bio Med
Beaumont Bio Med announced a voluntary recall of all unexpired aqueous/alcohol-based products due to possible microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619587.htm Source: FDA website
Drug Recall 09-05-18
Actemra SC
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) alone or in combination with methotrexate in individuals 2 years of age or older. Source: FDA website
New Indication 09-13-18
Xelpros
The Food and Drug Administration (FDA) approved Xelpros™ (latanoprost ophthalmic emulsion) for the reduction of elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Formulation 09-14-18
Lumoxiti
The Food and Drug Administration (FDA) approved Lumoxiti™ (moxetumomab pasudotox injection) for adults with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies including treatment with a purine nucleoside analog (PNA). Source: FDA website
New Drug 09-13-18
Years to Your Health
The Food and Drug Administration (FDA) is alerting consumers not to use any products made by Years to Your Health of Irving, Texas due to risk for serious infection. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm620564.htm Source: FDA website
Drug Warning 09-14-18
Furosemide
SCA Pharmaceuticals announced a voluntary recall of 7 lots of the injectable product furosemide 100 mg in 0.9% sodium chloride 100 mg bag due to visible particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619776.htm Source: FDA website
Drug Recall 09-06-18
Pharm D Solutions
Pharm D Solutions announced a voluntary recall of all sterile compounded drugs due to a potential lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620054.htm Source: FDA website
Drug Recall 09-11-18
Coagadex
The Food and Drug Administration (FDA) approved Coagadex® (coagulation factor X, human, injection) in adults and children for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and for perioperative management of bleeding to include individuals with moderate hereditary Factor X deficiency. Source: FDA website
New Indication 09-26-18
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets and oral suspension) in pediatric individuals as young as 4 years old for the treatment of partial-onset seizures. Source: FDA website
New Indication 09-28-18
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) prefilled syringe formulation for the treatment of allergic asthma and chronic idiopathic urticaria. Source: FDA website
New Formulation 10-01-18
Xyosted
The Food and Drug Administration (FDA) approved Xyosted™ (testosterone auto-injection) for once weekly testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 10-01-18
Symjepi
The Food and Drug Administration (FDA) approved Symjepi™ (epinephrine injection) 0.15 mg dose to treat anaphylaxis in pediatric individuals who weigh between 33 and 65 pounds. Source: FDA website
New Formulation 09-28-18
Arikayce
The Food and Drug Administration (FDA) approved Arikayce® (amikacin liposome oral inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) in individuals who do not respond to conventional treatment. Source: FDA website
New Drug 09-28-18
Ajovy
The Food and Drug Administration (FDA) approved Ajovy™ (fremanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-17-18
Copiktra
The Food and Drug Administration (FDA) approved Copiktra™ (duvelisib capsules) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after 2 or more prior therapies and relapsed or refractory follicular lymphoma (FL) after 2 or more prior therapies. Source: FDA website
New Drug 09-14-18
Vizimpro
The Food and Drug Administration (FDA) approved Vizimpro® (dacomitinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Source: FDA website
New Drug 09-27-18
Emgality
The Food and Drug Administration (FDA) approved Emgality™ (galcanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-27-18
Libtayo
The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab injection) for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Source: FDA website
New Drug 09-28-18
Zhejiang Huahai Pharmaceuticals
The Food and Drug Administration (FDA) placed Zhejiang Huahai Pharmaceuticals on import alert while the active pharmaceutical ingredient (API) manufacturer determines how impurities were introduced into its valsartan products. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm613916.htm Source: FDA website
Drug Warning 09-28-18
Pen Needles
The Food and Drug Administration (FDA) is providing recommendations to promote the safe use of pen needles used to inject medications from pen injectors. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm621788.htm Source: FDA website
Drug Warning 09-27-18
Biolyte Laboratories
BioLyte Laboratories announced a voluntary recall of certain lots of NeoRelief, a homeopathic topical gel for muscle cramping and restlessness, due to possible microbial contamination. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620481.htm Source: FDA website
Drug Recall 09-12-18
Robaxin
Endo International announced a voluntary recall of 2 lots of Robaxin 750 mg tablets 100 count bottle packs due to incorrect daily dosing information on label. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622008.htm Source: FDA website
Drug Recall 09-28-18
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Source: FDA website
New Indication 10-11-18
Liletta
The Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) to prevent pregnancy for up to 5 years. Source: FDA website
New Indication 10-16-18
Stiolto Respimat
The Food and Drug Administration (FDA) approved Stiolto® Respimat® (tiotropium bromide/olodaterol oral inhalation) for long-term, once-daily maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 10-11-18
Yutiq
The Food and Drug Administration (FDA) approved YutiqTM (fluocinolone acetonide intravitreal implant) for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. Source: FDA website
New Drug 10-15-18
Talzenna
The Food and Drug Administration (FDA) approved TalzennaTM (talazoparib capsules) for individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer based on an FDA-approved companion diagnostic. Source: FDA website
New Drug 10-16-18
Sprayology
Sprayology announced a voluntary recall of all lots within expiry from 10/18-07/22 of its aqueous-based homeopathic product line for human use due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622919.htm Source: FDA website
Drug Recall 10-11-18
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of hidradenitis suppurativa in adolescents. Source: FDA website
New Indication 10-16-18
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) as an add-on maintenance therapy in individuals with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Source: FDA website
New Indication 10-19-18
Afluria, Afluria Quadrivalent
The Food and Drug Administration (FDA) approved Afluria® (trivalent, inactivated influenza vaccine injection) and Afluria® Quadrivalent (quadrivalent, inactivated influenza vaccine injection) for use in individuals 6 months and older. Both were previously indicated for individuals 5 years of age and older. Source: FDA website
New Indication 10-23-18
Xyrem
The Food and Drug Administration (FDA) approved Xyrem® (sodium oxybate oral solution) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric individuals ages 7 to 17 years old with narcolepsy. Source: FDA website
New Indication 10-26-18
Invokana
The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Invokamet, Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) and Invokamet® XR (canagliflozin/metformin extended-release tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. Source: FDA website
New Indication 10-30-18
Sympazan
The Food and Drug Administration (FDA) approved Sympazan™ (clobazam oral film) as adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in individuals aged 2 years and older. Source: FDA website
New Formulation 11-05-18
Qmiiz ODT
The Food and Drug Administration (FDA) approved Qmiiz ODT™ (meloxicam orally disintegrating tablets) for the treatment of osteoarthritis, rheumatoid arthritis, and juvenile idiopathic arthritis. Source: FDA website
New Formulation 10-19-18
Egrifta
The Food and Drug Administration (FDA) approved Egrifta™ (tesamorelin injection) single-vial formulation for the treatment of excess abdominal visceral adipose tissue (VAT) in human immunodeficiency virus (HIV)-infected individuals with lipodystrophy. Source: FDA website
New Formulation 11-05-18
Khapzory
The Food and Drug Administration (FDA) approved Khapzory™ (levoleucovorin injection) for rescue after high-dose methotrexate therapy in individuals with osteosarcoma, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and the treatment of individuals with metastatic colorectal cancer in combination with fluorouracil. Source: FDA website
New Formulation 10-23-18
Bijuva
The Food and Drug Administration (FDA) approved Bijuva (estradiol/progesterone capsules) for the treatment of moderate to severe vasomotor symptoms due to menopause in women who have a uterus. Source: FDA website
New Formulation 10-29-18
Dsuvia
The Food and Drug Administration (FDA) approved Dsuvia (sufentanil sublingual tablets) for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours. Source: FDA website
New Formulation 11-02-18
Lorbrena
The Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib tablets) for individuals with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Source: FDA website
New Drug 11-02-18
Xofluza
The Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil tablets) for the treatment of acute uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours. Source: FDA website
New Drug 10-24-18
EpiPen
The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that the labels attached to some EpiPen® (epinephrine 0.3mg auto-injectors) and EpiPen Jr® (epinephrine 0.15mg auto-injectors), and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. Contact your healthcare provider with any questions. More details may be viewed at: https://www.drugs.com/fda_alerts.html Source: FDA website
Drug Warning 11-02-18
Genetic Tests
The Food and Drug Administration (FDA) warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624725.htm Source: FDA website
Drug Warning 11-01-18
Aurobindo Pharma Limited
Aurobindo Pharma Limited announced a voluntary recall of 22 batches of irbesartan due to the presence of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624547.htm Source: FDA website
Drug Recall 10-26-18
Sciegen Pharmaceuticals
Sciegen Pharmaceuticals announced a voluntary recall of certain lots of irbesartan tablets due to detection of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624593.htm Source: FDA website
Drug Recall 10-30-18
Ortho-Novum 1/35 and Ortho-Novum 7/7/7
Janssen Pharmaceuticals announced a voluntary recall of one lot of Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol tablets) and two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol tablets) due to incorrect Veridate dispenser instructions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625012.htm Source: FDA website
Drug Recall 11-02-18
Promise Pharmacy
Promise Pharmacy announced a voluntary recall of one lot of prednisolone and gatifloxacin ophthalmic solution due to small particulate floating in the solution. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm623994.htm Source: FDA website
Drug Recall 10-22-18
Empliciti
The Food and Drug Administration (FDA) approved Empliciti® (elotuzumab injection) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Source: FDA website
New Indication 11-06-18
Bryhali
The Food and Drug Administration (FDA) approved Bryhali™ (halobetasol propionate topical lotion) for the treatment of plaque psoriasis in adults. Source: FDA website
New Formulation 11-07-18
Kadesh Incorporation
Kadesh, Inc. announced a voluntary recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625305.htm Source: FDA website
Drug Recall 11-07-18
Sandoz
Sandoz announced a voluntary recall of one lot of losartan potassium hydrochlorothiazide tablets 100mg/25mg due to the trace amount of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625492.htm Source: FDA website
Drug Recall 11-09-18
Astagraf XL
The Food and Drug Administration (FDA) approved Astagraf XL® (tacrolimus extended-release capsules) for prophylaxis of organ rejection in kidney transplant in combination with other immunosuppressants in pediatric individuals 4 years of age and older. Source: FDA website
New Indication 11-29-18
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment, of individuals with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 12-06-18
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ophthalmic insert) for the treatment of ocular pain after ophthalmic surgery. Source: FDA website
New Formulation 12-03-18
Valsartan-containing products from Mylan
Mylan announced an expansion of its voluntary recall to include all lots of valsartan-containing products within expiry due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627647.htm Source: FDA website
Drug Recall 12-05-18
Tris Pharma
Tris Pharma announced a voluntary recall of 3 lots of Infants' Ibuprofen Concentrated Oral Suspension due to higher concentrations of ibuprofen. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627780.htm Source: FDA website
Drug Recall 12-06-18
Viread
The Food and Drug Administration (FDA) approved Viread® (tenofovir disoproxil fumarate tablets) for use in chronic hepatitis B in individuals aged 2 to less 12 years old. Source: FDA website
New Indication 12-13-18
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) for pediatric individuals 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Source: FDA website
New Indication 12-14-18
Tolsura
The Food and Drug Administration (FDA) approved Tolsura™ (SUBA-itraconazole capsules) for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). The new formulation is expected to have improved bioavailability. Source: FDA website
New Formulation 12-12-18
Promise Pharmacy
The Food and Drug Administration (FDA) alerted health care providers and consumers not to use drug products intended to be sterile from Promise Pharmacy due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm627929.htm Source: FDA website
Drug Recall 12-07-18