Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Mylan Pharmaceuticals receives FDA final approval for Anastrozole Tablets ANDA

Mylan Inc. 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.

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.

Source:

Mylan Inc.

Source: www.news-medical.net