Noven gets FDA "approvable letter" for Stavzor

The US Food and Drug Administration has issued an "approvable letter "related to the New Drug Application for Miami, USA-based Noven Pharmaceuticals' Stavzor (delayed-release valproic acid) capsules in 125mg, 250mg and 500mg strengths. This is for the use of the drug 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 has requested certain non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The agency has not requested additional human studies or clinical data, says Noven.

Because the NDA for Stavzor references Abbott Laboratories' Depakote (valproic acid), final approval is also subject to the expiration of any applicable exclusivity periods benefiting the latter. Based on receipt of the approvable letter, interaction with Banner Pharmacaps (the NDA holder and developer of the product), and its understanding of Depakote exclusivity, Noven says it continues to expect Stavzor final approval, at the latest, by the end of July 2008.