Drugs
Postmarketing Drug Safety Evaluation Summaries Completed from January 2011 through June 2011
Product Name: Trade (Active Ingredient) NDA/BLA Number | 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. | 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.
| 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. |
