Mylan Receives FDA Approval For Additional Strength Of Generic Restoril

Mylan Pharmaceuticals, a subsidiary of Mylan has received approval from the FDA for 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. Mylan has begun shipping the product.

Currently, Mylan has 118 ANDAs pending FDA approval representing $82.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, which represent $16.7 billion in annual brand sales, according to IMS Health.

Mylan is a biopharmaceutical company focused on respiratory and allergy therapies. The company maintains broad product portfolios, supported by a robust product pipeline.