Mylan Inc.has announced that its subsidiary Mylan Pharmaceuticals Inc. has receivedapproval from the FDA for its supplementalAbbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg.This strength is in addition to Mylan's currently marketed 15 mg and 30 mgstrengths of the product.
Temazepam Capsules are the generic version of Mallinckrodt's Restoril(R),a sleep aid, which had total U.S. sales of approximately $6 million for the 12months ending March 31, according to IMS Health. Mylan has begun shipping thisproduct.