Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for
its generic contraceptive norgestimate and ethinyl estradiol tablets.
Glenmark Generics Inc, a subsidiary of Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the US health regulator for Norgestimate and Ethinyl Estradiol tablets in the strengths of 0.25 mg/0.035 mg, a statement from the company read.
The
tablets are generic version of Janssen Pharmaceuticals Inc oral contraceptive Ortho Cyclen tablets.
Citing IMS Health data for the 12-month period ending December 2011, the company said norgestimate and ethinyl estradiol tablets of strength 0.25 mg/0.035 mg garnered total market sales of approximately $88 million.
The company currently has 79 generic products authorised for distribution in the US market and 39 ANDA's pending approval with the USFDA, Glenmark said.
Today's approval is Glenmark's tenth female hormonal product authorised for distribution by the USFDA, it added.
Shares of Glenmark Pharmaceuticals were on Monday trading at Rs 307.40 in the morning trade on the Bombay Stock Exchange, down 0.47 per cent from its previous close.
With PTI inputs 
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