Mylan Receives FDA Approval For Additional Strength Of Generic Restoril(R)

Mylan Inc. (NASDAQ: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated 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 mg strengths of the product. Temazepam Capsules are the generic version of Mallinckrodt’s Restoril®, a sleep aid, which had total U.S.

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Filed under: Sleep / Sleep Disorders on June 30th, 2009