Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Jun 29 2010

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 Anastrozole Tablets, 1 mg, the generic version of AstraZeneca's Arimidex® Tablets, a treatment for early breast cancer.

Anastrozole Tablets had U.S. sales of approximately $917 million for the 12 months ending March 31, 2010, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 136 ANDAs pending FDA approval representing $94 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $20.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.