Glenmark Gets US Regulator's Nod for Oral Contraceptive Drug

New Delhi: Glenmark Pharmaceuticals on Wednesday said it has received final approval from the US Food and Drug Administration (FDA) to sell oral contraceptive tablets in the American market.

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

The product is a generic version of Bayer's Yaz tablets.

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".

As of 1:51 p.m., shares in Glenmark were trading almost 3 per cent higher at Rs 1194.40 apiece on the BSE, outperforming the broader markets that were up 0.4 per cent.