Mylan has announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets, which is the generic version of Bayer’s Yasmin@ Tablets. Mylan’s partner Famy Care Ltd. 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 for use by women to prevent pregnancy.
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, had U.S. sales of approximately $137.6 million for the 12 months ending June 30, 2015, according to IMS Health. The immediate availability of this product represents Mylan’s thirteenth oral contraceptive launch in the U.S.
Currently, Mylan has 266 ANDAs pending FDA approval representing $99.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, according to IMS Health.
