Postmarket Drug and Biologic Safety Evaluations Completed from July 2016 – September 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
Acticlate (doxycycline hyclate) tablets, for oral use NDA 205931 July 25, 2014	For treating: Rickettsial infections Sexually transmitted infections Respiratory tract infections Specific bacterial infections Ophthalmic infections Anthrax, including inhalation anthrax (post-exposure) For use as: An alternative treatment for selected infections when penicillin is contraindicated An adjunctive therapy for acute intestinal amebiasis and severe acne Prophylaxis of malaria	No new safety issues were identified.	No regulatory actions required at this time.
Arnuity Ellipta (fluticasone furoate inhalation powder) for oral inhalation NDA 205625 August 20, 2014	For the once-daily 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.
Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye NDA 206289 July 18, 2014	For treating cycloplegia and mydriasis For the penalization of the healthy eye in the treatment of amblyopia	No new safety issues were identified.	No regulatory actions required at this time.
Belsomra (suvorexant) tablets, for oral use NDA 204569 (NME) August 13, 2014	For treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance	Two safety issues were identified from postmarketing adverse event reports: Paradoxical reactions Worsening insomnia	FDA continues to evaluate adverse event reports of paradoxical reactions and worsening insomnia to determine if regulatory action is required.
Bunavail (buprenorphine and naloxone) buccal film NDA 205637 June 6, 2014	For the maintenance treatment of opioid dependence	Two safety issues were identified from postmarketing adverse event reports: Product quality issues resulting in opioid withdrawal symptoms Inadequate dose conversion from a different opioid maintenance treatment to Bunavail.	FDA continues to evaluate adverse event reports of product quality issues and inadequate dose conversion to determine if regulatory action is required.
Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets NDA 200063 September 10, 2014	For use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m² or greater (obese) 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)	Two safety issues were identified from postmarketing adverse event reports: Loss of consciousness Abuse	FDA continues to evaluate adverse event reports of loss of consciousness and abuse to determine if regulatory action is required.
Desvenlafaxine extended-release tablet, for oral use NDA 204150 March 4, 2013	For treating major depressive disorder (MDD)	No new safety issues were identified.	No regulatory actions required at this time.
Eylea (aflibercept) injection, for intravitreal injection BLA 125387 (NME) November 18, 2011	For treating: Neovascular (wet) age-related macular degeneration (AMD) Macular edema following retinal vein occlusion (RVO) Diabetic macular edema (DME) Diabetic retinopathy (DR) in patients with DME	No new safety issues were identified.	No regulatory actions required at this time.
Flonase Allergy Relief (fluticasone proprionate) nasal spray NDA 205434 July 23, 2014	For the temporary relief of symptoms due to hay fever or other upper respiratory allergies, including: Nasal congestion Runny nose Sneezing Itchy nose Itchy, watery eyes	No new safety issues were identified.	No regulatory actions required at this time.
Jublia (efinaconazole) topical solution, 10% NDA 203567 (NME) June 6, 2014	For the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes	No new safety issues were identified.	No regulatory actions required at this time.
Kerydin (tavaborole) topical solution, 5% NDA 204427 (NME) July 7, 2014	For the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes	No new safety issues were identified.	No regulatory actions required at this time.
Mozobil (plerixafor) injection, for subcutaneous use NDA 022311 (NME) December 15, 2008	For use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma	No new safety issues were identified.	No regulatory actions required at this time.
Nymalize (nimodipine) oral solution NDA 203340 May 10, 2013	For improving neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V)	No new safety issues were identified.	No regulatory actions required at this time.
Ofev (nintedanib) capsule, for oral use NDA 205832 (NME) October 15, 2014	For treating idiopathic pulmonary fibrosis (IPF)	No new safety issues were identified.	No regulatory actions required at this time.
Pennsaid (diclofenac sodium) topical solution, 2% w/w, for topical use NDA 204623 January 16, 2014	For treating the pain of osteoarthritis of the knee(s)	No new safety issues were identified.	No regulatory actions required at this time.
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% and 10% NDA 203510 March 21, 2013	For dilating the pupil	No new safety issues were identified.	No regulatory actions required at this time.
Promacta (eltrombopag) tablets, for oral use NDA 022291 (NME) November 20, 2008	For treating: Thrombocytopenia in adult and pediatric patients 6 years of age and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy Severe aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy	No new safety issues were identified.	No regulatory actions required at this time.
Tanzeum (albiglutide) for injection, for subcutaneous use BLA 125431 (NME) April 15, 2014	For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus	Three safety issues were identified from postmarketing adverse event reports: Incorrect technique of product preparation for administration Incorrect technique of administration Pen leakage during administration	FDA continues to evaluate adverse event reports of incorrect techniques of product preparation and administration, as well as pen leakage during administration to determine if regulatory action is required.
Vazculep (phenylephrine hydrochloride) injection for intravenous use NDA 204300 June 27, 2014	For treating clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia	One safety issue of product selection error between Vazculep (phenylephrine hydrochloride) and Bloxiverz (neostigmine methylsulfate) was identified from postmarketing adverse event reports.	FDA continues to evaluate medication error reports of wrong product selection to determine if regulatory action is required.
Zyrtec Allergy (cetirizine hydrochloride) orally disintegrating tablets NDA 022578 September 3, 2010	For the temporary relief of symptoms due to hay fever or upper respiratory allergies, including: Runny nose Itching, watery eyes Sneezing Itching of the nose or throat	No new safety issues were identified.	No regulatory actions required at this time.