Lupin receives FDA approval for Oral contraceptive

Lupin Pharmaceuticals, a subsidiary of Lupin has received US FDA approval for the generic version of Watson Laboratories' Lutera tablets

Lupin Pharmaceuticals has received final approval for its Levonorgestrel and Ethinyl Estradiol tablets USP,0.1 mg / 0.02 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Watson Laboratories' Lutera 28 tablets. Lupin is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa according to IMS.

Lupin's Levonorgestrel and Ethinyl Estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women, who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its generic product shortly.

Lutera tablets had annual US sales of approximately $ 103.6 million (IMS MAT Sept 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.Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales.

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