New Delhi: Glenmark Pharmaceuticals has received the final nod from the US health regulator for generic oral contraceptive norgestimate ethinyl estradiol tablets.
In a BSE filing, the company said Glenmark Pharmaceuticals USA has been granted final approval by the US Food & Drug Administration (USFDA) 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".
Approval has been granted for generic version of Ortho Tri-cyclen Lo tablets of Janssen Pharmaceuticals, Inc. According to IMS Health sales data for the 12 months to December 2015, the Ortho Tri-cyclen Lo tablets achieved annual sales of around $503.9 million, Glenmark said.
The company's current portfolio consists of 107 products authorised for distribution in the US marketplace and 62 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.