Postmarket Drug and Biologic Safety Evaluations Completed from October 2016 – December 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
Argatroban injection in 5% dextrose, for intravenous infusion only NDA 201743   May 9, 2011	For use as prophylaxis or for treating thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) For use as an anticoagulant in patients with or at risk for HIT undergoing percutaneous coronary intervention	No new safety issues were identified.	No regulatory actions required at this time.
Benlysta (belimumab) injection, for intravenous use only   BLA 125370 (NME)   March 9, 2011	For treating adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy	No new safety issues were identified.	No regulatory actions required at this time.
Bloxiverz (neostigmine methylsulfate) injection, for intravenous use   NDA 204078   May 31, 2013	For reversing the effects of non-depolarizing neuromuscular blocking agents after surgery	No new safety issues were identified.	No regulatory actions required at this time.
Ceftazidime for injection USP and dextrose injection USP, for intravenous use   NDA 050823   June 13, 2011	For treating the following infections caused by susceptible isolates of the designated microorganisms: lower respiratory tract infections skin and skin-structure infections bacterial septicemia bone and joint infections gynecologic infections central nervous system infections	A safety issue of status epilepticus was identified from postmarketing adverse event reports.	FDA continues to evaluate the safety issue of status epilepticus to determine if regulatory action is required.
Coartem (artemether and lumefantrine) tablets, for oral use   NDA 022268 (NME)   April 7, 2009	For treating acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above	A safety issue of hemolytic anemia, possibly associated with post-artemisinin delayed hemolysis, was identified from postmarketing adverse event reports.	FDA is evaluating adverse event reports of hemolytic anemia to determine if regulatory action is required.
Dotarem (gadoterate meglumine) injection, for intravenous use   NDA 204781 (NME)   March 20, 2013	For use with magnetic resonance imaging in brain (intracranial), spine and associated tissues in patients 2 years of age and older to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity	No new safety issues were identified.	No regulatory actions are required at this time.
Harvoni (ledipasvir and sofosbuvir) tablets, for oral use   NDA 205834 (NME)   October 10, 2014	For use with or without ribavirin for treating patients with chronic hepatitis C virus genotype 1, 4, 5, or 6 infection	No new safety issues were identified.	No regulatory actions required at this time.
Hysingla ER (hydrocodone bitartrate) extended-release tablets, for oral use   NDA 206627   November 20, 2014	For managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate	No new safety issues were identified.	No regulatory actions required at this time.
Invokamet (canagliflozin and metformin hydrochloride) tablets, for oral use   NDA 204353   August 8, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin is appropriate	A safety issue of nephrolithiasis was identified from postmarketing adverse event reports.	FDA continues to evaluate adverse event reports of nephrolithiasis to determine if regulatory action is required.
Jardiance (empagliflozin) tablets, for oral use   NDA 204629 (NME)   August 1, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes	Two safety issues were identified from postmarketing adverse event reports: Acute kidney injury Pancreatitis	In December 2016, the “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the prescribing information and the patient package insert were updated to include information regarding acute kidney injury. FDA has completed its review of pancreatitis and has determined that no regulatory action is needed at this time.
Kcentra (prothrombin complex concentrate (human))   BLA 125421   April 29, 2013	For the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding or need an urgent surgery/invasive procedure	Reports of product label confusion and wrong dose administration were identified.	June 30, 2017 FDA completed its review of reports of product label confusion and wrong dose administration. In February 2017, the product labeling and the “Dosage and Administration” section of the prescribing information were revised to clarify the supplied dose. No further regulatory action is required at this time.
Lymphoseek (technetium Tc 99m tilmanocept) injection, for subcutaneous, intradermal, subareolar, or peritumoral use   NDA 202207 (NME)   March 13, 2013	A radioactive diagnostic agent for use with or without scintigraphic imaging: to locate lymph nodes draining a primary tumor site in patients with solid tumors as part of intraoperative management; to guide sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma	No new safety issues were identified.	No regulatory actions required at this time.
Movantik (naloxegol) tablets, for oral use   NDA 204760 (NME)   September 16, 2014	For treating opioid-induced constipation in adult patients with chronic non-cancer pain	No new safety issues were identified.	No regulatory actions required at this time.
Namzaric (memantine and donepezil hydrochlorides) extended-release capsules, for oral use   NDA 206439   December 23, 2014	For the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily	No new safety issues were identified.	No regulatory actions required at this time.
Paricalcitol injection, for intravenous use   NDA 201657   October 21, 2014	An active vitamin D2 analog for preventing and treating secondary hyperparathyroidism associated with chronic kidney disease Stage 5	No new safety issues were identified.	No regulatory actions required at this time.
Rytary (carbidopa and levodopa) extended-release capsules, for oral use   NDA 203312   January 7, 2015	For treating Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication	No new safety issues were identified.	No regulatory actions required at this time.
Soolantra (ivermectin) cream, 1%, for topical use   NDA 206255   December 19, 2014	For treating inflammatory lesions of rosacea	Two safety issues were identified from postmarketing adverse event reports: Contact dermatitis Allergic contact dermatitis	FDA is evaluating adverse event reports of contact dermatitis and allergic contact dermatitis to determine if regulatory action is required.
Subsys (fentanyl) sublingual spray   NDA 202788   January 4, 2012	For managing breakthrough pain in adult opioid tolerant cancer patients	A safety issue of a burning sensation at the application site was identified from postmarketing adverse event reports.	FDA is evaluating adverse event reports of a burning sensation at the application site to determine if regulatory action is required.
Testosterone gel, for topical use   NDA 203098   January 31, 2013	For replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone	No new safety issues were identified.	No regulatory actions required at this time.
Tobi Podhaler (tobramycin) inhalation powder, for oral inhalation use   NDA 201688   March 22, 2013	For managing cystic fibrosis patients with Pseudomonas aeruginosa	No new safety issues were identified.	No regulatory actions required at this time.
Trulicity (dulaglutide) injection, for subcutaneous use   BLA 125469 (NME)   September 18, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus	A safety issue of device malfunction was identified from postmarketing adverse event reports.	FDA continues to evaluate reports of device malfunction to determine if regulatory action is required.
Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use   NDA 205649   October 29, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate	No new safety issues were identified.	No regulatory actions required at this time.