PITTSBURGH, April 25, 2011 /PRNewswire/ -- 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.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.