FDA tentatively approves Stavzor

FDA granted tentative approval to Noven (NOVN) for an NDA for Stavzor valproic acid to treat seizures and manic episodes associated with bipolar disorder and to prevent migraines. Final approval is subject to the expiration of exclusivity for Depakote divalproex from Abbott (ABT) on July 29, 2008. Stavzor received an approvable letter from FDA in October (See BioCentury Extra, Wednesday, Oct. 24, 2007). ...