Lupin receives FDA approval for Kurvelo tablets

Pharma major, Lupin  Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its oral contraceptive Kurvelo® Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Teva Branded Pharmaceuticals (Teva) 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. Lupin's Kurvelo® tablets is a  Levonorgestrel and Ethinyl estradiol combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Lupin is marketing its Kurvelo® tablets in 21 light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl estradiol and seven pink inert tablets (without hormones). This dosage regimen is identical to that of Nordette®.

Nordette® Tablets had annual U.S sales of approximately USD 59 million (IMS MAT Jun 2012 sales).