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FDA approves Glenmark oral contraceptive drug

The US Food and Drug Administration (FDA) has approved Glenmark Generics' abbreviated new drug application (ANDA) oral contraceptive drugs, Norgestimate and Ethinyl Estradiol Tablets, USP 0.18mg/0.035 mg, 0.215mg/0.035mg and 0.25/0.035mg.

Glenmark Generics‘ Norgestimate and Ethinyl Estradiol Tablets, USP 0.18mg/0.035 mg, 0.215mg/0.035mg and 0.25/0.035mg are the generic version of Ortho McNeil Janssen Pharmaceuticals’ Ortho Tri-Cyclen used to prevent unwanted pregnancy.

Ethinyl estradiol and norgestimate contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary).

Ethinyl estradiol and norgestimate is also used to treat severe acne.