Glenmark gets US nod for oral contraceptive Mircette copy

Drug maker Glenmark Pharmaceuticals ' US generics arm has received final approval from US Food and Drugs Administration to sell Desogestrel and Ethinyl Estradiol tablets of 0.15 mg/0.02 mg strengths.

Glenmark said it will market the product as Viorele, which is a copy of Mircette tablets by Teva Women's Health Inc, and plans to start shipping immediately.

The drug is indicated as oral contraceptive for prevention of pregnancy in women. Desogestrel and Ethinyl Estradiol had total market sales of about USD 98 million for year ending December 2011, Glenmark said citing IMS Health data.

This approval is Glenmark's ninth oral contraceptive approved for distribution by the US drug regulator.

The company said overall it has 78 generic products authorized for distribution in the US and 40 ANDAs (Abbreviated new drug applications) are pending approval with the US FDA.

Glenmark shares were up 1.6% at Rs 310 on NSE in morning trade.