Mylan N.V. (NASDAQ, TASE: MYL), today 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. (1)
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.
(1) Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. The risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.
SOURCE Mylan N.V.