Noven Pharma: FDA issues approvable letter for Stavzor |
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Published
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Tue, 23 Oct 2007 22:54
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SAN FRANCISCO (Thomson Financial) - Noven Pharmaceuticals Inc. said late Tuesday the Food and Drug Administration has issued an approvable letter related to the new drug application for Stavzor in 125mg, 250mg and 500mg strengths.The Miami-based company said the approvable letter relates to the use of Stavzor in the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types, and prophylaxis of migraine headaches.The agency has requested certain non-clinical information, including additional in vitro dissolution data, as a condition to final approval.The FDA has not requested additional human studies or clinical data, the comapny added.Noven said it continues to expect Stavzor final approval by the end of July 2008, at the latest.Noven share closed the regular session up 2 cents at $14.17.Gabriel MadwaygmCOPYRIGHTCopyright Thomson Financial News Limited 2007. All rights reserved.The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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