Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the 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.