A new type of delayed-release valproic acid capsule is one step closer to receiving final approval for sale in the U.S. by the Food and Drug Administration (FDA). The new drug will be marketed under the brand name Stavzor by Noven Pharmaceuticals.
The delayed release valproic acid capsules, when they receive final approval, will be available in 125mg, 250mg and 500mg strengths. The FDA approval is for 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 new drug application 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.
Noven expects to receive Stavzor’s final FDA approval by the end of July 2008.
Stavzor was developed using Banner’s patent-pending EnteriCare enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor in the U.S. 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.
“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,” said Robert C. Strauss, Noven’s President, CEO & Chairman. “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.”