Mylan launches Letrozole Tablets for hormone receptor-positive early stage breast cancer

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Letrozole Tablets USP, 2.5 mg, under a previously announced settlement and license agreement with Novartis. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Letrozole Tablets and will market the product with a period of exclusivity.

Letrozole Tablets are the generic version of Novartis' Femara® Tablets, an adjuvant treatment for postmenopausal women with hormone receptor-positive early stage breast cancer. This product had U.S. sales of approximately $682 million for the 12 months ending Dec. 31, 2010, according to IMS Health.

Currently, Mylan has 165 ANDAs pending FDA approval representing $98.5 billion in annual sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $25.9 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.