The FDA has issued an approvable letter for Noven Pharmaceutical's Stavzor, a treatment for manic episodes associated with bipolar disorder, an adjunctive therapy in multiple seizure types, and prophylaxis of migraine headaches. The FDA wants non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The good news for Noven is that the agency won't require any additional human studies or clinical data. Noven says that it is anticipating full approval by July 2008.
- see this release from Noven