Singapore, Dec 20, 2011: US-based generic and specialty pharmaceutical company Mylan has announced that its subsidiary Mylan Pharmaceuticals has received final approval from the US 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 September 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.

According to IMS Health, currently, Mylan has 166 ANDAs pending FDA approval representing $98.3 billion in annual sales. 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.

Source:BioSpectrum Bureau