Postmarket Drug and Biologic Safety Evaluations Completed from January - March 2016

 

Product Name: Trade (active ingredient) with Dosage form NDA/BLA Number Approval Date	Major Indications	Summary of Findings from Evaluation	Actions taken and Ongoing Surveillance Activities
Adrenalin (epinephrine injection) for intramuscular and subcutaneous use NDA 204640 December 18, 2013	For emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.	Adverse event reports of cardiomyopathy were identified.	The Overdosage section of the label was updated to include information on cardiomyopathy.
Aleve PM (naproxen sodium 220 mg/diphenhydramine hydrochloride 25 mg) NDA 205352 January 16, 2014	For relief of occasional sleeplessness when associated with minor aches and pains.	Potential for misuse of product for sleep without pain, resulting in inappropriate exposure to Nonsteroidal Anti-inflammatory Drugs (NSAIDs).	FDA is evaluating this potential safety issue to determine if regulatory action is required.
Anoro Ellipta (umeclidinium bromide and vilanterol) inhalation powder, for oral inhalation NDA 203975 New Molecular Entity (NME) December 18, 2013	For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).	No new safety issues were identified.	No regulatory actions required at this time.
Aubagio (teriflunomide) tablet, for oral use NDA 202992 (NME) September 12, 2012	For treating patients with relapsing forms of multiple sclerosis.	No new safety issues were identified.	No regulatory actions required at this time.
Ecoza (econazole nitrate) topical foam, 1%, for topical use NDA 205175 October 24, 2013	For the topical treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.	No new safety issues were identified.	No regulatory actions required at this time.
Imbruvica (ibrutinib) capsule, for oral use NDA 205552 (NME) November 13, 2013	For treating patients with: Mantle cell lymphoma Chronic lympocytic leukemia Waldenström’s macroglobulinemia	Three safety issues were identified from adverse event reports: Central nervous system hemorrhage Hepatic failure Visual disturbances	The Warnings and Precautions section as well as the Adverse Reactions section of the label were updated to include information about intracranial hemorrhage, hepatic failure, and visual disturbance. No further regulatory actions required at this time.
Incruse Ellipta (umeclidinium bromide) inhalation powder, for oral inhalation NDA 205382 April 30, 2014	For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.	No new safety issues were identified.	No regulatory actions required at this time.
Morphine Sulfate injection, for intravenous or intramuscular use NDA 204223 October 30, 2013	For the management of pain not responsive to non-narcotic analgesics.	Two safety issues were identified from adverse event reports: Medication errors Sleep apnea	FDA continues to evaluate: medication error reports of syringe malfunction to determine if regulatory action is required. sleep apnea to determine if regulatory action is required.
Olysio (simeprevir) capsule, for oral use NDA 205123 (NME) November 22, 2013	For treating chronic hepatitis C virus (HCV) (genotype 1 or 4) infection as a component of a combination of antiviral treatment regimen.	Two safety issues were identified from adverse event reports: Angioedema Anaphylaxis	No regulatory actions required at this time.
Sovaldi (sofosbuvir) tablet, for oral use NDA 204671 (NME) December 6, 2013	For treating chronic hepatitis C virus (HCV) (genotype 1, 2, 3, or 4) infection as a component of a combination antiviral treatment regimen.	No new safety issues were identified.	No regulatory actions required at this time.
Spherusol (Coccidioides immitis spherule derived skin test antigen) solution for intradermal injection BLA 125354 July 29, 2011	For detecting delayed-type hypersensitivity to Coccidioides immitis in individuals 18 to 64 years of age with a history of pulmonary coccidioidomycosis.	No new safety issues were identified.	No regulatory actions required at this time.