Pharma major Lupin Ltd. announced that its subsidiary Lupin Pharmaceuticals Inc. had received final approval for its oral contraceptive Kurvelo tablets - Levonorgestrel and Ethinyl Estradiol tablets, USP - 0.15 mg/0.03 mg from the US FDA to market a generic version of Teva Branded Pharmaceuticals Nordette tablets - Levonorgestrel and Ethinyl Estradiol tablets, USP -, 0.15 mg/0.03 mg.
Lupin's Kurvelo tablets are the AB-rated generic equivalent of Teva's Nordette tablets. Kurvelo tablets is a Levonorgestrel and Ethinyl Estradiol combined oral contraceptive indicated for the prevention pf pregnancy in women who elect to use this product as a method of contraception.
The company is marketing its Kurvelo tablets in 21 light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl Estradoil and seven pink inert tablets (without hormones). This dosage regimen is identical to that of Nordette.
As per IMS MAT June 2012 sales data, Nordette tablets had annual sales of around $59 million in the US.
At the BSE, Lupin closed Thursday's trading at Rs.570.50, down 0.18 percent from the previous close.
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