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 USD 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.