Drugs
Postmarket Drug Safety Evaluation Summaries Completed from July 2011 through December 2011
Product Name: Trade (Active Ingredient) NDA/BLA Number | Major Indication(s) | Summary of Evaluation Findings | Actions Taken and Ongoing Surveillance Activities |
|---|---|---|---|
Acuvail 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 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 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
| 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
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 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:
| 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. |
Embeda 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
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. |
Lysteda 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
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. | No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
Multaq
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 |
| 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. |
OraVerse
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
NDA 020947 November 4, 2009 | For the treatment of signs and symptoms of | 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
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
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:
| No unlabeled or unexpected serious adverse events were identified. | No regulatory actions required at this time. |
| Sumavel Dosepro (Sumatriptan succinate)
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)
| 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)
| 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)
| As an adjunct to diet and exercise to:
| 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)
| 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)
| 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
NDA 022211
| 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. |
