Noven’s Licensed CNS Drug Receives FDA’s Tentative Approval

Noven has reported that the FDA has issued a tentative approval letter related to the new drug application for Stavzor in 125mg, 250mg and 500mg strengths.

The tentative approval relates to the use of Stavzor 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.

Based on receipt of the tentative approval letter and Noven’s understanding of Depakote exclusivity, the company expects FDA final approval of Stavzor by the end of July 2008.

Robert Strauss, president, CEO & chairman of Noven, said: “Stavzor launch and production planning is underway in support of an expected 2008 launch through the Noven/JDS sales and marketing organization.”