Mylan Receives Approval for Promethazine Hydrochloride Tablets, USP

PITTSBURGH, Sept. 9, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Promethazine Hydrochloride (HCl) Tablets USP, 12.5 mg, 25 mg and 50 mg. Promethazine HCl Tablets are used to relieve the symptoms of certain allergic reactions, such as perennial and seasonal allergic rhinitis.

Promethazine HCl Tablets had U.S. sales of approximately $42 million for the 12 months ending June 30, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 161 ANDAs pending FDA approval representing $97.1 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit For more information about generic drugs, please visit

SOURCE Mylan Inc.