Tentative FDA appro for Noven's Stavzor

The US Food and Drug Administration has issued a tentative approval letter related to the New Drug Application for Noven Pharmaceuticals' Stavzor (valproic acid delayed-release capsules) in 125mg, 250mg and 500mg strengths. This relates to the use of the drug 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 states in the letter that it has completed its review of the amended Stavzor NDA and that it is tentatively approved, which generally means that the agency has concluded that a drug product has met all required quality, safety and efficacy standards but, because of existing patents and/or exclusivity rights, it cannot yet be marketed in the USA. The NDA for Stavzor, which was submitted by Banner Pharmacaps (the NDA holder and developer of the product) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, references Abbott Laboratories' Depakote (valproic acid) product. Based on receipt of the letter and Noven's understanding of Depakote exclusivity, the firm says it continues to expect final FDA approval of its product by the end of July 2008.