Mylan Launches First Generic Version of Femara Tablets
Generic drugmaker Mylan Inc. said Monday it has launched a generic version of Novartis' breast cancer treatment Femara.
Mylan Inc. announced Monday 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.
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