Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) 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 approximately $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. Forty of these pending ANDAs are potential first-to-file opportunities, representing $21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.
SOURCE Mylan Inc.