USFDA gives approval to Glenmark Pharmaceuticals for oral contraceptive

Written by Meghna A Singhania Published On 2015-08-21T14:51:43+05:30 | Updated On 21 Aug 2015 2:51 PM IST

USFDA gives approval to Glenmark Pharmaceuticals for oral contraceptive

Glenmark Pharmaceuticals will be now selling the oral contraceptive -- drospirenone and ethinyl estradiol tablets, the generic version of Bayer’s yaz tablets -- in the US market. The company has recently reported to have received a final approval from USFDA.

"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol tablets USP, 3 mg/0.02 mg," the company said in a BSE filing.

Glenmark said it plans to commence shipping of drospirenone and ethinyl Estradiol tablets immediately.

Citing IMS Health sales data, the company said for the 12 months period ending June, "the Yaz market achieved annual sales of approximately $170.1 million".

Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751