June 21, 2010 (FinancialWire) — Mylan Inc. (NASDAQ: MYL) said that its subsidiary Matrix Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, the generic version of Merck & Co.'s Zocor Tablets, a treatment for high cholesterol.

The product will be distributed by Mylan Pharmaceuticals Inc.

Simvastatin Tablets had U.S. sales of around $361 million for the 12 months ending March 31, 2010, according to IMS Health.

Currently, Mylan has 137 ANDAs pending FDA approval representing $94.8 billion in annual brand sales, according to IMS Health. According to the firm, forty of these pending ANDAs are potential first-to-file opportunities, representing $21 billion in annual brand sales, for the 12 months ending December 31, 2009 according to IMS Health.

Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm that has customers in more than 140 countries and territories.

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