The city-based drug maker Glenmark Pharmaceuticals announced that its US-based arm, Glenmark Generics has received United States Food and Drug Administration (USFDA) approval to market 'Briellyn', a generic oral contraceptive drug in the US market.
Briellyn is the combination of Norethindrone and Ethinyl Estradiol, a generic version of the Ovcon 35 tablets of Warner Chilcott,
Inc. The product will be marketed under the trade name Briellyn. Briellyn provides a continuous 28 day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets.
The company's arm receives approval for its abbreviated new drug application (ANDA) for Norethindrone and Ethinyl Estradiol
combination, used for the prevention of pregnancy. The company receives approval to sell the tablet in the strength of USP 0.4 mg/ 0.035 mg.
According to the data provided by IMS Health, the combination has achieved $30 million for the 12 months period ending December 2010.
Source: IMS Health
