NEW YORK (Thomson Financial) - Noven Pharmaceuticals said it received a 'tentative' approval letter from the U.S. Food and Drug Administration related to its new drug application for Stavzor for use in the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
The FDA said in its letter that it completed the review of the amended NDA for Stavzor, and concluded that Stavzor has met required safety, quality and efficacy standards. 'Tentative' approval means the drug can't yet be marketed in the U.S. due to existing patent and/or exclusivity rights.
On Oct. 23, Noven said the FDA issued an approvable letter related to the NDA for Stavzor, but had requested certain non-clinical information, including dissolution data, as a condition of final approval.
Noven said it still expects final approval of the NDA, which was submitted by Banner Pharmacaps, by the end of July 2008, given its receipt of the tentative approval letter and its understanding of the exclusivity of Abbott Laboratories' Depakote product.
Noven's stock closed Wednesday's regular session down 5 cents at $14.50. Tomi Kilgore tk1 COPYRIGHT Copyright 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.