Postmarket Drug and Biologic Safety Evaluations Completed from April 2016 – June 2016

 

Product Name: Trade (active ingredient) with Dosage form NDA/BLA Number ("NME" indicates New Molecular Entity)  Approval Date	Major Indications	Summary of Findings from Evaluation	Actions taken and Ongoing Surveillance Activities
Asmanex HFA (mometasone furoate) inhalation aerosol, for oral inhalation NDA 205641 April 25, 2014	For maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.	No new safety issues were identified.	No regulatory actions required at this time.
Bivigam (immune globulin intravenous (human), 10% liquid) BLA 125389 December 19, 2012	For treating primary humoral immune deficiency.	No new safety issues were identified.	No regulatory action is required at this time.
Farxiga (dapagliflozin) tablet, for oral use NDA 202293 (NME) January 8, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.	Adverse event reports of acute kidney injury and severe dehydration were identified.	FDA updated the “Warnings and Precautions” section of the package insert and the Medication Guide to include information about the risk of acute kidney injury. FDA continues to monitor for adverse event reports of severe dehydration to determine if further evaluation is required.
Forfivo XL (bupropion hydrochloride) extended-release tablet, for oral use NDA 022497 November 10, 2011	For treating patients with major depressive disorder.	A potential signal for abuse by inappropriate routes of administration was identified.	FDA is evaluating the need for regulatory action.
Granix (tbo filgrastim) injection, for subcutaneous use BLA 125294 (NME) August 29, 2012	For reducing the duration of severe neutropenia in patients with non-myeloid malignancies who receive myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.	Five safety issues were identified from postmarketing adverse event reports: Kidney injury (glomerulonephritis)   Acute febrile neutrophilic dermatosis (Sweet syndrome) Asthenia Diarrhea Fatigue	FDA is evaluating the need for regulatory action.
Nexium 24HR (esomeprazole magesium) delayed-release capsule, for oral use NDA 204655 March 28, 2014	For treating frequent heartburn (occurs 2 or more days a week) in adults 18 years of age and older.	No new safety issues were identified.	No regulatory actions required at this time.
Onfi (clobazam) oral suspension NDA 203993 December 14, 2012	For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.	No new safety issues were identified.	No regulatory actions required at this time.
Otezla (apremilast) tablet, for oral use NDA 205437 (NME) March 21, 2014	For treating: Adult patients with active psoriatic arthritis Patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.	No new safety issues were identified.	No regulatory actions required at this time.
Oxtellar XR (oxcarbazepine) extended-release tablet, for oral use NDA 202810 October 19, 2012	For use as an adjunctive therapy in the treatment of partial seizures in adults. For use as an adjunctive therapy in the treatment of partial seizures in children 6 years of age to 17 years of age.	No new safety issues were identified.	No regulatory actions required at this time.
Sodium chloride injection, USP, 0.9% NDA 202832 January 6, 2012	For diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injections.	No new safety issues were identified.	No regulatory actions required at this time.
Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablet, for oral use NDA 204031 March 11, 2014	For managing acute pain for which non-opioid analgesics are inadequate.	No new safety issues were identified.	No regulatory actions required at this time.
Xtandi (enzalutamide) capsule, for oral use NDA 203415 (NME) August 31, 2012	For treating patients with metastatic castration-resistant prostate cancer.	Five safety issues were identified from postmarketing adverse event reports: Hypersensitivity Anemia Rash Nausea Vomiting	FDA continues to evaluate adverse event reports of hypersensitivity, anemia, rash, nausea, and vomiting to determine if regulatory action is required.