Glenmark gets US nod for another oral contraceptive generic

Glenmark Pharma 's US Generics arm has received final approval from US Food and Drugs Administration for its abbreviated new drug application (ANDA) for oral contraceptive Norgestimate and Ethinyl Estradiol tablets 0.25/0.035 mg strength.

Glenmark's approved product is the generic version of Ortho Cyclen tablets marketed by Janssen Pharmaceuticals.

Norgestimate and Ethinyl Estradiol had total sales of about USD 88 million for year ended December 2011 in the US market, the pharma company said citing IMS Health data.

This is Glenmark's tenth hormonal product authorized for distribution by the US FDA.

Last week, Glenmark had said it received US FDA nod to sell Desogestrel and Ethinyl Estradiol tablets, a copy of Mircette oral contraceptive tablets marketed by Teva Women's Health Inc.

Glenmark shares were down 0.6% at Rs 308.40 on NSE in morning trade on Monday.