FDA issues Stavzor approvable letter

Noven (NOVN) said FDA issued an approvable letter for an NDA for Stavzor valproic acid to treat seizures, including epilepsy, and manic episodes associated with bipolar disorder and to prevent migraines. The company said FDA requested non-clinical information, including additional in vitro dissolution data. The agency did not request additional clinical studies or clinical data, according to the company. ...