Postmarket Drug and Biologic Safety Evaluations Completed from January 2017 – March 2017

 

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
Cosentyx (secukinumab) injection, for subcutaneous use   BLA 125504 (NME)   January 21, 2015	For treating adults with: Plaque psoriasis Psoriatic arthritis Ankylosing spondylitis	Five potential safety issues were identified from postmarketing adverse event reports: Sepsis and infection-related deaths Neutropenia-related serious infection Eczema Lichen planus/lichenoid mucositis Medication errors and device-related events	FDA is evaluating adverse event reports of sepsis and infection-related deaths, neutropenia-related serious infection, eczema, lichen planus/lichenoid mucositis, medication errors, and device-related events to determine if regulatory action is required.
Cuvposa (glycopyrrolate) oral solution   NDA 022571   July 28, 2010	For reducing chronic, severe drooling in patients who are 3 to 16 years of age with neurologic conditions associated with problem drooling	No new safety issues were identified.	No regulatory actions required at this time.
Cysview Kit (hexaminolevulinate hydrochloride) intravesical solution for bladder instillation only   NDA 022555   May 28, 2010	For cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy	No new safety issues were identified.	No regulatory actions required at this time.
Dysport (abobotulinumtoxinA) injection, for intramuscular use   BLA 125274 (NME)   April 29, 2009	For treating: Cervical dystonia in adults Upper limb spasticity in adults Lower limb spasticity in pediatric patients 2 years of age and older For cosmetic use to temporarily improve the appearance of moderate to severe glabellar lines	Two potential safety issues were identified from postmarketing adverse event reports: Anaphylaxis Dry eyes	FDA is evaluating adverse event reports of dry eyes to determine if regulatory action is required. On June 14, 2017, a labeling supplement was approved that included the addition of information in the “Adverse Reactions; Postmarketing Experience” section of labeling pertaining to reports of hypersensitivity reactions, including anaphylaxis.
Edurant (rilpivirine) tablets, for oral use   NDA 202022 (NME)   May 20, 2011	For treating human immunodeficiency virus type 1 (HIV-1) infection, in combination with other antiretroviral agents, in treatment-naïve patients with HIV-1 ribonucleic acid or RNA less than or equal to 100,000 copies/milliliter	No new safety issues were identified.	No regulatory actions required at this time.
Epaned Kit (enalapril maleate) oral solution   NDA 204308   August 13, 2013	For treating: Hypertension in adults and children older than one month Symptomatic heart failure Asymptomatic left ventricular dysfunction	No new safety issues were identified.	No regulatory actions required at this time.
Esomeprazole strontium delayed-release capsules, for oral use   NDA 202342   August 6, 2013	For treating gastroesophageal reflux disease in adults For reducing risk of nonsteroidal anti-inflammatory drug-associated gastric ulcer in adults For eradicating H. pylori to reduce the risk of duodenal ulcer recurrence in adults For treating pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults	No new safety issues were identified.	No regulatory actions required at this time.
Glyxambi (empagliflozin and linagliptin) tablets, for oral use   NDA 206073   January 30, 2015	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate	No new safety issues were identified.	No regulatory actions required at this time.
MenHibrix             (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)   BLA 125363   June 14, 2012	Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b	No new safety issues were identified.	No regulatory actions required at this time.
Meropenem for Injection USP and Sodium Chloride Injection USP in Duplex container, for intravenous use   NDA 202106   April 30, 2015	For treating: Complicated skin and skin structure infections Complicated intra-abdominal infections Bacterial meningitis	No new safety issues were identified.	No regulatory actions required at this time.
Neostigmine methylsulfate  injection, for intravenous use   NDA 203629   January 8, 2015	For the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery	No new safety issues were identified.	No regulatory actions required at this time.
Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for topical ophthalmic administration   NDA 206276   January 30, 2015	For treating ocular itching associated with allergic conjunctivitis	No new safety issues were identified.	No regulatory actions required at this time.
Perjeta (pertuzumab) injection, for intravenous use   BLA 125409 (NME)   June 8, 2012	For use in combination with trastuzumab and docetaxel for treating patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. For use in combination with trastuzumab and docetaxel as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 centimeters or node positive) as part of a complete treatment regimen for early breast cancer.	Two potential safety issues were identified from postmarketing adverse event reports: Angioedema Tumor lysis syndrome	FDA continues to evaluate adverse event reports of angioedema and tumor lysis syndrome to determine if regulatory action is required.
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10%   NDA 207926   January 15, 2015	For dilating the pupil	No new safety issues were identified.	No regulatory actions required at this time.
Pomalyst (pomalidomide) capsules, for oral use   NDA 204026 (NME)   February 8, 2013	For use in combination with dexamethasone to treat patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy	Three potential safety issues were identified from postmarketing adverse event reports: Ischemic colitis Pancreatitis Progressive multifocal leukoencephalopathy	FDA is evaluating adverse event reports of ischemic colitis, pancreatitis, and progressive multifocal leukoencephalopathy to determine if regulatory action is required.
Potassium chloride oral solution   NDA 206814   December 22, 2014	For the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient	No new safety issues were identified.	No regulatory actions required at this time.
Savaysa (edoxaban) tablets, for oral use   NDA 206316 (NME)   January 8, 2015	For reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation   For treating deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial therapy with a parenteral anticoagulant therapy	No new safety issues were identified.	No regulatory actions required at this time.
Saxenda (liraglutide) injection, for subcutaneous use   NDA 206321   December 23, 2014	For use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia)	No new safety issues were identified.	No regulatory actions required at this time.
Simponi Aria (golimumab) injection, for intravenous use   BLA 125433 (NME)   July 18, 2013	For treating adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate	No new safety issues were identified.	No regulatory actions required at this time.
Toujeo (insulin glargine injection) U-300, for subcutaneous use   NDA 206538   February 25, 2015	A long-acting human insulin analog for improving glycemic control in adults with diabetes mellitus	No new safety issues were identified.	No regulatory actions required at this time.
Trumenba (Meningococcal Group B Vaccine)   BLA 125549   October 29, 2014	For active immunization to prevent invasive disease caused by Neisseria meningitides serogroup B in individuals 10 through 25 years of age	No new safety issues were identified.	No regulatory actions required at this time.
Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) co-packaged for oral use   NDA 206619 (NME)   December 19, 2014	For treating adult patients with chronic hepatitis C virus genotype 1 infection	No new safety issues were identified.	No regulatory actions required at this time.
Xofigo (radium Ra-223 dichloride) injection, for intravenous use   NDA 203971 (NME)   May 15, 2013	For treating castration-resistant prostate cancer in patients with symptomatic bone metastases and no known visceral metastatic disease	No new safety issues were identified.	No regulatory actions required at this time.
Yervoy (ipilimumab) injection, for intravenous use   BLA 125377 (NME)   March 25, 2011	For treating unresectable or metastatic melanoma For use as an adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 millimeter who have undergone complete resection, including total lymphadenectomy	Six potential safety issues were identified from postmarketing adverse event reports: Neutropenia and/or febrile neutropenia Thrombocytopenia Retinal detachment Blindness Rhabdomyolysis Acute febrile neutrophilic dermatosis	FDA continues to evaluate adverse event reports to determine if regulatory action is required.