Drugs

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.

 

Page Last Updated: 10/06/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English