Glenmark Pharmaceuticals has get the final approval from the US health regulator for generic oral contraceptive norgestimate ethinyl estradiol tablets.
The company said in a BSE filing that Glenmark Pharmaceuticals USA has been granted the US Food & Drug Administration (USFDA) final approval for “norgestimate and ethinyl estradiol tablets USP, 0.18 mg/0.025 mg, 0.215 mg/ 0.025 mg and 0.25 mg/0.025mg”.
The approval has been given for generic version of Ortho Tri-cyclen Lo tablets of Janssen Pharmaceuticals, Inc.