Novast Labs' Generic Ethinyl Estradiol; Ethynodiol Diacetate Receives Approval in US
Novast Labs’ Generic Ethinyl Estradiol; Ethynodiol Diacetate Receives Approval In The US
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.
Jai Pharma`s Generic Ethynodiol Diacetate And Ethinyl Estradiol approved in US to prevent ovulation