Lupin’s subsidiary gets USFDA approval for oral contraceptive Kurvelo Tablets

18 Oct 2012 Evaluate

Pharma major, 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 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. The company would be 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.

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti?Infective and NSAID space and holds global leadership positions in the Anti?TB and Cephalosporin segment. 

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3 rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).

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