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U.S. Department of Health and Human Services

Drugs

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Postmarket Drug Safety Evaluation Summaries Completed from July 2011 through December 2011

  

Product Name: Trade (Active Ingredient)   

NDA/BLA Number 
Approval Date

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

Acuvail
(Ketorolac tromethamine ophthalmic solution 0.45%)
  

NDA 022427
 

June 28, 2010

For the treatment of pain and inflammation following cataract surgery.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

AK-FLUOR
(Fluorescein sodium injection, 10% and 25%)
  

NDA 022186
 

August 8, 2008

For diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Banzel
(Rufinamide)
  

NDA 021911
 

November 14, 2008

For adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Bepreve
(Bepotastine besilate)  


NDA 022288 


September 8, 2009 

For the treatment of itching associated with allergic conjunctivitis.

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

Codeine Sulfate
(Codeine sulfate) 

 

NDA 022402

 

July 16, 2009

For the treatment of mild to moderate pain where the use of an opioid analgesic is appropriate.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Effient
(Prasugrel)
  

NDA 022307
 

July 10, 2009

For the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows:

  • Patients with unstable angina or, non-ST-elevation myocardial infarction.
  • Patients with ST-elevation myocardial infarction when managed with either primary or delayed PCI.

Adverse event reports of hypersensitivity (allergic reactions) and intracranial hemorrhage were identified.

Hypersensitivity was added to the Warnings and Precautions, Patient Counseling Information, and Medication Guide sections of the labeling in September 2011.

FDA determined that the current labeling, which includes the risk of bleeding in a Boxed Warning and in the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections, is adequate.

Embeda
(Morphine sulfate/Naltrexone hydrochloride)
  

NDA 022321
 

August 13, 2009

For management of moderate to severe pain when a continuous, around- the-clock opioid analgesic is needed for an extended period of time.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

InterSol Solution
(Platelet Additive Solution 3)

 

NDA BN080041
 

December 9, 2009

An isotonic solution to replace a proportion of the plasma used in the storage of AMICUS™-derived leukoreduced apheresis platelets.

No new safety concerns were identified.

No regulatory actions required at this time.

Intuniv
(Guanfacine hydrochloride)

 

NDA 022037
 

September 2, 2009

For the treatment of Attention Deficit Hyperactivity Disorder as monotherapy and as adjunctive therapy to stimulant medications.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Invega Sustenna
(Paliperidone palmitate)

 

NDA 022264
 

July 31, 2009 

For the acute and maintenance treatment of schizophrenia in adults.

Adverse event reports of medication errors involving use of the device (syringe) were identified.

FDA is continuing to evaluate this issue to determine if regulatory action is required.
Livalo
(Pitavastatin)

 

NDA 022363
 

August 3, 2009

 

For patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol. 

Adverse event reports of interstitial lung disease, hepatitis, and jaundice were identified.

FDA is continuing to evaluate interstitial lung disease issues to determine if regulatory action is required.

FDA is continuing to evaluate the hepatic events to determine if the current labeling, which includes liver enzyme abnormalities in the Warnings and Precautions section, is adequate.

Lysteda
(Tranexamic acid)
  

NDA 022430
 

November 13, 2009 

For the treatment of cyclic heavy menstrual bleeding.

 

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Metozolv ODT
(Metoclopramide hydrochloride) 


NDA 022246
 

September 4, 2009

 

For the relief of symptomatic gastroesophageal reflux for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

For the relief of symptoms in adults associated with acute and recurrent diabetic gastroparesis (Diabetic Gastric Stasis).

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Multaq
(Dronedarone)

 

NDA 022425
 

July 1, 2009

To reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

Adverse event reports of heart failure, liver failure, pneumonitis, pulmonary fibrosis, and increase in creatinine were identified.

Drug Safety Communication
The Warnings and Precautions and Adverse Reactions sections of the labeling for Multaq, which included liver failure, were updated in January 2011, to include additional information about liver failure.

Pneumonitis and pulmonary fibrosis were added to the Adverse Reactions section of the labeling in June 2011.

Increase in creatinine was added to the Warnings and Precautions section of the labeling in August 2011.

Drug Safety Communication
The Boxed Warning and Warnings and Precautions sections of the labeling for Multaq, which included heart failure, were updated in December 2011, to include additional information about serious heart failure, including death.

Onglyza
(Saxagliptin)

 

NDA 022350
 

July 31, 2009

 

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

Adverse event reports of hypersensitivity (allergic reactions) and pancreatitis were identified.

Hypersensitivity reaction was added to the Contraindications, Warning and Precautions, Adverse Reactions, and Patient Counseling sections of the labeling in November 2011.

Pancreatitis was added to the Warnings and Precautions and Patient Counseling sections of the labeling in November 2011.

OraVerse
(Phentolamine mesylate)

 

NDA 022159
 

May 9, 2008  

For reversal of soft-tissue anesthesia.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Oxaliplatin injection
(Oxaliplatin injection)

 

NDA 022160
 

May 22, 2009 

For adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor and treatment of advanced colorectal cancer.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.


 

Pennsaid
(Diclofenac sodium)

 

NDA 020947
 

November 4, 2009 

For the treatment of signs and symptoms of
osteoarthritis of the knees.

Two medication errors reporting incorrect route of administration were reported.

A medication error review is being performed. No other regulatory actions required at this time.

Relistor
(Methylnaltrexone bromide) 

 

NDA 021964
 

April 24, 2008 

For the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

Adverse event reports of drug withdrawal syndrome were identified.

FDA is continuing to evaluate this issue to determine if regulatory action is required.

Renvela
(Sevelamer carbonate) 

 

NDA 022318
 

August 12, 2009

For the control of serum phosphorus in patients with chronic kidney disease on dialysis.

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.

Saphris
(Asenapine maleate)

NDA 022117
 

August 13, 2009

For the treatment of schizophrenia and acute treatment, as monotherapy or adjunctive therapy, of manic or mixed episodes associated with bipolar I disorder.Adverse event reports of hypersensitivity (allergic reactions) were identified.Drug Safety Communication
Hypersensitivity was added to the Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling sections of the labeling in August 2011.
Silenor
(Doxepin hydrochloride)

NDA 022036
 

March 17, 2010 

For the treatment of insomnia characterized by difficulties with sleep maintenance.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Simponi
(Golimumab)

BLA 125289
 

April 4, 2009

For the treatment of:

  • Moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate
  • Active psoriatic arthritis in adults, alone or in combination with methotrexate
  • Active Ankylosing Spondylitis in adults
No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time. 
Sumavel Dosepro
(Sumatriptan succinate)


NDA 022239
 

July 15, 2009

For the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Twynsta
(Amlodipine besylate and telmisartan)


NDA 022401


October 16, 2009

For the treatment of hypertension alone or with other antihypertensive agents and as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Valturna
(Aliskiren hemifumarate and valsartan)


NDA 022217


September 16, 2009

For the treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Welchol
(Colesevelam hydrocholoride)


NDA 022362


October 2, 2009

As an adjunct to diet and exercise to:

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with a statin.
  • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy.
  • improve glycemic control in adults with type 2 diabetes mellitus.
Adverse event reports of dysphagia (difficulty in swallowing) Welchol oral suspension were identified.Dysphagia associated with the oral suspension and tablet was added to the Adverse Reactions section of the labeling in January 2012. [Dysphagia associated with the tablet was added to the Warning and Precautions section of the labeling in July 2011.]
Zegerid OTC
(Omeprazole/Sodium bicarbonate)


NDA 022281


December 1, 2009

For the treatment of heartburn (not more than 14 days).No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.
Zenpep
(Pancrelipase)


NDA 022210


August 27, 2009

For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.No unlabeled or unexpected serious adverse events were identified.No regulatory actions required at this time.

Zirgan
(Ganciclovir ophthalmic gel, 0.15%) 

 

NDA 022211

 

September 15, 2009

For the treatment of acute herpetic keratitis (dendritic ulcers).

No unlabeled or unexpected serious adverse events were identified.

No regulatory actions required at this time.