Thursday, December 29, 2016
Mylan N.V., announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan's product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Zovia® 1/50E-28 Tablets (Watson). Mylan's subsidiary, Jai Pharma Limited, 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.
Currently, Mylan has more than 240 ANDAs pending FDA approval representing approximately $95.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $32.5 billion in annual brand sales, for the 12 months ending June 30, 2016, according to IMS Health.
