Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics, has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration for Norgestimate and Ethinyl Estradiol tablets.
This is Glenmark’s fourth oral contraceptive product approval and the fifth hormone product approval for the US market.
Norgestimate and Ethinyl Estradiol Tablets USP are indicated for the treatment of moderate acne vulgaris in females of at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and today’s approval marks their fifth female hormonal product authorised for distribution by U S Food and Drug Administration (USFDA).