Healthcare Industry News: topiramate
News Release - July 30, 2008
Banner Pharmacaps Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules
HIGH POINT, N.C.--(HSMN NewsFeed)--Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, today announced that the US Food & Drug Administration (FDA) has granted final approval for the Company’s New Drug Application (NDA) for Valproic Acid Delayed Release soft gelatin capsules in the 125 mg, 250 mg, and 500 mg strengths. This drug is approved for use in the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in multiple seizure types, and for prophylaxis of migraine headaches. It has a similar pharmacokinetic profile to Abbott Laboratories Depakote® delayed release tablets. Banner has partnered with Noven Pharmaceuticals, Inc., who will market and sell this product under the brand name of Stavzor™ through its Noven Therapeutics subsidiary.Stavzor is the first pharmaceutical product to utilize Banner’s patent-pending EnteriCare™ technology. This innovative concept allows for the direct delivery of the active pharmaceutical ingredient without encountering the challenges typical to enteric coated softgels. With EnteriCare, the enteric features reside within the shell; thereby avoiding the propensity of coated softgels to crack and chip, potentially compromising the integrity of the functional coating.
Important Product Safety Information
Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment. Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of valproate should be weighed against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions have been reported after the initiation of valproate therapy. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with valproate in clinical studies were nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhea, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, thrombocytopenia, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea and tinnitus.
About Banner Pharmacaps Inc.
Banner Pharmacaps Inc. is a global drug delivery and specialty pharmaceutical company which is developing a proprietary portfolio of unique products and oral dosage forms that include the enhanced technologies of enteric and controlled release softgels, as well as Soflet® Gelcaps. Headquartered in High Point, North Carolina, Banner is committed to the research, development, and manufacture of quality healthcare products to serve our global community. Additional information about Banner is available at http://www.banpharm.com.
The parent company of Banner is VION N.V., an international food group that produces high-quality foodstuffs and ingredients for humans and animals. VION has annual sales in excess €7 Billion, with 16,200 employees worldwide. The head office of VION is in Son en Breugel, The Netherlands.
About Noven Pharmaceuticals:
Noven Pharmaceuticals, Inc.(Nasdaq: NOVN ) is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven’s specialty pharmaceutical unit. For more information about Noven, visit www.noven.com.
Source: Banner Pharmacaps
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