Mylan (MYL) Receives FDA Approval for ANDA for Temazepam Capsules USP, 22.5 mg
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Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. FDA for its supplemental Abbreviated New Drug Application for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan's currently marketed 15 mg and 30 mg strengths 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 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product.
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