Glenmark gets USFDA approval for oral contraceptive drug

The company's US-based arm, Glenmark Generics Inc, has got final approval for its abbreviated new drug application (ANDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a filing to the Bombay Stock Exchange.

The combination of Norethindrone and Ethinyl Estradiol, a generic version of the Ovcon 35 tablets of Warner Chilcott, Inc, will be marketed under the trade name Briellyn and distribution is expected to start immediately, the company added.

According to IMS Health, for the 12-month period ending December, 2010, this combination achieved sales of USD 30 million.

According to the company, Briellyn provides a continuous 28-day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol.
Glenmark remains the only Indian company to be granted ANDA approval for an oral contraceptive product and today's approval marks their fourth female hormonal product authorised for distribution by the USFDA, it said.

According to IMS Health, total market sales of Glenmark's current hormonal product line is nearly USD 141 million for the 12-month period ending December, 2010.

Shares of Glenmark Pharma were being quoted at 278.25 on the Bombay Stock Exchange in late afternoon trade today, up 2.43 per cent from their previous close.