Mylan N.V. announced the US launch of exemestane tablets, 25 mg, a generic version of the reference listed drug, Pfizer's Aromasin tablets.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of certain types of breast cancer in women after menopause.
Mylan is the largest supplier of cancer medicines by volume in the US, and the launch of exemestane tablets, 25 mg, adds to the company's robust oncology franchise. Exemestane tablets, 25 mg, had US sales of approximately $100 million for the 12 months ending January 31, 2017, according to IMS Health.
Currently, Mylan has 240 ANDAs pending FDA approval representing approximately $100.8 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $39 billion in annual brand sales, for the 12 months ending December 31, 2016, according to IMS Health.