Glenmark arm gets final US FDA nod for oral contraceptive

Glenmark Generics Ltd said Wednesday that the US Food and Drug Administration has approved its US arm's drug Briellyn, a generic version of the female oral contraceptive Ovcon.

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. According to IMS Health for the 12 month period ending December 2010, this combination achieved sales of USD 30 million, the company said in a release.

The company will start selling the drug in the US shortly, it said.

"Total market sales of Glenmark's current hormonal product line is approximately USD 141 million for the 12 month period ending December 2010, according to IMS Health. The approval marks the fourth female hormonal product authorised for distribution in the US," the company release said.

Glenmark Generics Ltd is a privately-held subsidiary of the listed Glenmark Pharmaceuticals, and had been planning to go public. Recently, Glenmark top boss Glen Saldhana said that the initial public offering of Glenmark Generics had been put on the backburner.

At 1023 IST, Glenmark shares were traded at Rs 277, up 2% over the previous close.

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