New Delhi: Drug firm Glenmark Pharmaceuticals today said it has received final approval from the US health regulator 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 Food and Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol tablets in the strengths of 0.25 mg/0.035 mg, Glenmark Pharmaceuticals said in a statement.
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 USD 88 million.
The company currently has 79 generic products authorized 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 today trading at Rs 307.40 in the morning trade on BSE, down 0.47 per cent from its previous close.