Glenmark Receives USFDA Nod for Oral Contraceptive Drug

NEW DELHI: Glenmark Pharmaceuticals today said it has received final approval from the U.S. health regulator to sell oral contraceptive drospirenone and ethinyl estradiol tablets in the U.S. market.

"Glenmark Pharmaceuticals Inc., U.S.A 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.

The product is generic version 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 U.S. $170.1 million".

Glenmark's shares were trading at Rs 1,213.65 a piece, up 4.62 percent from their previous close on BSE.

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