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Lupin bags US FDA approval for oral contraceptive Kurvelo tablets
Our Bureau, Bengaluru | Friday, October 19, 2012, 12:15 Hrs  [IST]

Lupin's subsidiary Lupin Pharmaceuticals Inc., has 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 (Teva) Nordette tablets, 0.15 mg/0.03 mg.

Lupin’s Kurvelo tablets are the AB-rated generic equivalent of Teva’s Nordette tablets. Its Kurvelo tablet is a  oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. The company is marketing Kurvelo tablets in 21 light orange coloured 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 US sales of approximately USD 59 million (IMS MAT June 2012 sales).

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs.

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