Glenmark Pharma gets USFDA nod for ‘Briellyn’

PTI New Delhi | Updated on March 23, 2011

Glenmark Pharmaceuticals has said that its US-based unit has received final approval from the US health regulator to market a generic oral contraceptive drug, ‘Briellyn’, in the American market.

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 today.

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 the distribution is expected to start immediately, the company added.

According to IMS Health, for the 12-month period ended December, 2010, this combination achieved sales worth $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 the company’s 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 stood at nearly $141 million for the 12-month period ended December 2010.

The company shares were being quoted at 278.25 on the Bombay Stock Exchange in the late afternoon trade today, up 2.43 per cent from the previous close.

Published on March 23, 2011

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