Agency requires additional nonclinical data.
Noven Pharmaceuticals received a letter from the FDA for its drug related to bipolar disorder stating that while approvable, the agency requires more nonclinical information.
Among the additional information requested is in vitro dissolution data, according to Noven. The FDA has not requested additional human studies or clinical data, the company adds.
The letter is related to Stavzor™ in 125 mg, 250 mg, and 500 mg strengths. If approved, the drug will be indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
Because the NDA for Stavzor references Abbott Laboratories’ Depakote® product, final approval is also subject to the expiration of any applicable exclusivity periods benefiting Depakote. Noven thus expects Stavzor final approval at the latest by the end of July 2008.