Noven plays waiting game with Stavzor
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA granted tentative approval to Noven's Stavzor (valproic acid delayed-release) but is unable to finalize approval of the 505(b)(2) NDA until outstanding patents and exclusivity rights held by Abbott for the reference drug Depakote (divalproex) expire on July 29, 2008. Noven hopes to launch the drug, indicated for treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types, and prophylaxis of migraine headaches, in mid-2008. Stavzor will not be AB-rated or substitutable for Depakote...