PITTSBURGH — Mylan Pharmaceuticals Inc. has begun shipping letrozole tablets 2.5 mg, a treatment for postmenopausal women with early-stage breast cancer.
Parent company Mylan Inc. said Monday that it launched the product under a previously announced settlement and license agreement with Novartis.
Mylan reported that it was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification for letrozole tablets and will market the product with a period of exclusivity.
The letrozole tablets are the generic version of Novartis’ Femara Tablets, which last year had U.S. sales of about $682 million, according to figures IMS Health cited by Mylan.
Letrozole is intended to reduce the level of estrogen in postmenopausal women and, in turn, slow the growth of certain types of breast tumors.
