On March 13, 2017 Mylan N.V. (NASDAQ, TASE: MYL), reported the U.S. launch of Exemestane Tablets, 25 mg, a generic version of the reference listed drug, Pfizer’s Aromasin Tablets (Press release, Mylan, MAR 13, 2017, View Source [SID1234518093]). Mylan received final approval from the U.S. 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.

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Mylan is the largest supplier of cancer medicines by volume in the U.S., and the launch of Exemestane Tablets, 25 mg, adds to the company’s robust oncology franchise. Exemestane Tablets, 25 mg, had U.S. sales of approximately $100 million for the 12 months ending Jan. 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 Dec. 31, 2016, according to IMS Health.