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U.S. Department of Health and Human Services

Drugs

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Postmarketing Drug Safety Evaluation Summaries Completed from January 2011 through June 2011

     

Product Name: Trade (Active Ingredient)   

NDA/BLA Number 
Approval Date

Major Indication(s) Summary of Evaluation Findings Actions Taken and Ongoing Surveillance Activities

Asacol HD

(Mesalamine)

 

NDA 021830

 

May 29, 2008

For the treatment of moderately active ulcerative colitis.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Besivance (Besifloxacin HCl)

 

NDA 022308

 

May 28, 2009

For the treatment of bacterial conjunctivitis.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Colcrys

(Colchicine)

 

NDAs 022351; 022353; 022352

 

July 30, 2009; October 16, 2009; July 29, 2009

For the treatment of gout flares in adults. 
 

For the treatment of familial Mediterranean fever (FMF) in adults and children 4 years and older.

No unlabeled or unexpected serious adverse events were identified.

The MedGuide was revised to improve consumer readability.


No additional regulatory actions required at this time.

Creon

(Pancrelipase)

 

NDA 020725

 

April 30, 2009

For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

No unlabeled or unexpected serious adverse events were identified. No additional regulatory actions required at this time.

Dexilant

(Dexlansoprazole)

 

NDA 022287

 

January 30, 2009

For (1) healing of all grades of erosive esophagitis; (2) maintaining healing of erosive esophagitis and relief of heartburn; and (3) treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease.

Adverse event reports of acute renal failure, deafness, drug-induced hepatitis, exfoliative dermatitis, hypomagnesemia, hyponatremia, idiopathic thrombocytopenic purpura, pancreatitis, autoimmune hemolytic anemia, and cerebrovascular accident were identified.

The Warnings and Precautions section of the labeling for all of the proton pump inhibitors was updated May 2011, to include hypomagnesemia.

 

The Adverse Reactions section of the labeling for Dexilant was updated June 2011, to include the other events.

Edluar

(Zolpidem tartrate)

 

NDA 021997

 

March 13, 2009

For the short-term treatment of insomnia characterized by difficulty with sleep initiation.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Emend

(Fosaprepitant dimeglumine)

 

NDA 022023

 

January 25, 2008
In combination with other antiemetic agents in adults for (1) prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin and (2) prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Adverse event reports of infusion site reactions were identified. Some of these reactions were serious, involving swelling and redness of the entire arm.

FDA is continuing to evaluate these issues to determine if the current labeling, which includes these events in the Warnings and Precautions section, is adequate.

Exforge HCT

(Amlodipine besylate, Hydrochlorothiazide, and Valsartan)

 

NDA 022314

 

April 30, 2009

For the treatment of hypertension.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Fanapt

(Iloperidone)

 

NDA 022192

 

May 6, 2009

For the treatment of schizophrenia in adults.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Hiberix

(Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate])

 

BLA 125347

 

August 19, 2009

Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b.

No new safety concerns were identified.

No labeling changes required.

Lamictal ODT

(Lamotrigine)

 

NDA 022251

 

May 8, 2009

Adjunctive therapy in patients ≥2 years of age with partial seizures, primary generalized tonic-clonic seizures, or generalized seizures of Lennox-Gastaut syndrome. 


Monotherapy in patients ≥16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single anti-epileptic drug.


Maintenance treatment of Bipolar I Disorder in patients ≥18 years of age to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

No unlabeled or unexpected serious adverse events were identified.
No regulatory actions required at this time.

Lamictal XR

(Lamotrigine)

 

NDA 022115

 

May 29, 2009

Adjunctive therapy for primary generalized tonic-clonic seizures and partial onset seizures with or without secondary generalization in patients ≥13 years of age.  


Conversion to monotherapy in patients ≥13 years of age with partial seizures who are receiving treatment with a single anti-epileptic drug.
No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Plan B One-Step

(Rx and OTC) (Levonorgestrel 1.5 mg)

 

NDA 021998

 

July 10, 2009

Emergency contraception; for oral use.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Ryzolt

(Tramadol HCl extended release  tablets)

 

NDA 021745

 

December 30, 2008

For management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Savella

(Milnacipran)

 

NDA 022256

 

January 14, 2009

For management of fibromyalgia.

Adverse event reports of elevated blood pressure and heart rate, possibly more severe than reflected in the labeling were identified.

FDA is continuing to evaluate these issues to determine if the current labeling, which includes these events in the Warnings and Precautions section, is adequate.

Stavzor

(Valproic acid)

 

NDA 022152

 

July 29, 2008

For (1) acute treatment of manic episodes associated with bipolar disorder; (2) monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures and adjunctive therapy in patients with multiple seizure types that include absence seizures; and (3) prophylaxis of migraine headaches.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Ulesfia

(Benzyl alcohol)

 

NDA 022129

 

April 9, 2009

For the topical treatment of head lice infestation in patients 6 months of age and older.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.


 

Uloric

(Febuxostat)

 

NDA 021856

 

February 13, 2009

Xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Vectical

(Calcitriol)

 

NDA 022087

 

January 23, 2009

For the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.

Vimpat

(Lacosamide)

 

NDA 022253

 

October 28, 2008

For adjunctive therapy in partial-onset seizures in patients ≥17 years of age.

Adverse event reports of cardiac conduction and “rhythm problems” were identified.

FDA is continuing to evaluate these issues to determine if the current labeling, which includes these events in the Warnings and Precautions section, is adequate.

Zipsor liquid filled capsules

(Diclofenac potassium)

 

NDA 022202

 

June 16, 2009

Relief of mild to moderate acute pain in adults.

No unlabeled or unexpected serious adverse events were identified. No regulatory actions required at this time.