PITTSBURGH, Dec. 16, 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 Metoprolol Succinate Extended-release (ER) Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. This product is the generic version of AstraZeneca's Toprol-XL® Tablets, which are indicated for the treatment of hypertension.
Metoprolol Succinate ER Tablets had U.S. sales of approximately $1.78 billion for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan's launch of this product is representative of the company's strength in continuing to bring difficult-to-formulate medicines to market.
Currently, Mylan has 166 ANDAs pending FDA approval representing $98.3 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 www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
SOURCE Mylan Inc.