Noven Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has issued an approvable letter related to the New Drug Application (NDA) for Stavzor (delayed release valproic acid capsules) in 125mg, 250mg and 500mg strengths. 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 (including epilepsy), and prophylaxis of migraine headaches.
The FDA states in the letter that it has completed its review of the Stavzor NDA and that it is approvable. The FDA 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.
Because the NDA for Stavzor, submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote product, final approval is also subject to the expiration of any applicable exclusivity periods benefiting Depakote. Based on receipt of the approvable letter, interaction with Banner Pharmacaps Inc. (the NDA holder and developer of the product), and its understanding of Depakote exclusivity, Noven continues to expect Stavzor final approval, at the latest, by the end of July 2008.
Stavzor was developed using Banner's patent-pending EnteriCare enteric soft gelatine capsule delivery system. Noven acquired a license to market and sell Stavzor in the US as part of Noven's acquisition of JDS Pharmaceuticals in August 2007. Stavzor will be a branded product; it is not expected to be AB-rated to or generically substitutable for Depakote, nor will Depakote or any Depakote generics be substitutable for Stavzor. Promotion of the Stavzor brand will target primarily high-prescribing physicians through the Noven/JDS sales force.
"We are very pleased to announce that the FDA has issued an approvable letter for Stavzor, and we offer our congratulations to the Banner and JDS teams for this successful result. We are now working with Banner to satisfy the conditions to final approval as expeditiously as possible. Banner has advised that it expects to respond to the FDA's requests in the coming weeks. Concurrently, the Noven/JDS team has begun launch and production planning in anticipation of a 2008 launch of Stavzor," said Robert C. Strauss, president, CEO and chairman, Noven.
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatine capsules.
EnteriCare is a trademark of Banner; Depakote is of Abbott Laboratories or its affiliates.