FDA issues approvable letter to Noven for Stavzor
MIAMI Noven Pharmaceuticals has received an approval letter from the Food and Drug Administration for its drug Stavzor, which is used for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraines.
The FDA has requested some non-clinical information as a condition of final approval. Because the application references the drug Depakote, final approval is also subject to the expiration of any applicable exclusivity periods benefiting the drug.
Noven expects the final approval to be at the latest, by the end of July 2008. The drug will be available in 125 mg, 250 mg and 500 mg strengths.