Superpharm’s diazepam tablets
Executive Summary
Superpharm contends in July 23 letter to FDA that proposed withdrawal of its three diazepam ANDAs "should be rescinded" in light of a new in vivo bioavailability study and in vitro dissolution and stability data that demonstrate bioequivalency of its diazepam to Roche's Valium. The submission was filed to support Superpharm's request for a hearing.