FDA issues tentative approval for Noven's Stavzor

MIAMI Noven Pharmaceuticals Thursday announced that the Food and Drug Administration has issued a tentative approval letter for Stavzor delayed release capsules.

The drug is indicated for treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

Stavzor (valproic acid delayed release capsules) was developed using Banner Pharmacaps’ patent-pending EnteriCare enteric soft gelatin capsule delivery system. Noven acquired a license to market and sell Stavzor in the United States as part of its acquisition of JDS Pharmaceuticals in August 2007. Banner submitted the new drug application for Stavzor in 125mg, 250mg and 500mg strengths. The FDA stated in the letter that it has completed its review of the amended Stavzor NDA and that it is tentatively approved.

The NDA for Stavzor, Noven stated, does reference Abbott Laboratories’ Depakote product; however, if approved for marketing, Stavzor will be a branded product, and not AB-rated to or generically substitutable for Depakote, nor will Depakote or any Depakote generics be substitutable for Stavzor.

“We are very pleased that Banner’s response to the FDA’s October 2007 approvable letter for Stavzor was deemed a complete response by the FDA, and that the FDA has granted tentative approval of this important new product for the treatment of three indications,” said Robert Strauss, Noven’s President, chief executive officer & Chairman. “Stavzor launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization.”