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Lupin Gets US FDA Final Nod To Market Generic Seasonale Tablets

Pharma major Lupin Ltd. announced that its subsidiary Lupin Pharmaceuticals Inc. had received final approval for its 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 Seasonale tablets - Levonorgestrel and Ethinyl Estradiol tablets, USP, 0.15 mg/0.03 mg.

Levonorgestrel and Ethinyl Estradiol tablets, USP, 0.15 mg/0.03 mg are the AB-rated generic equivalent of Teva's Seasonale tablets. Lupin's Levonorgestrel and Ethinyl Estradiol are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

The company is marketing Levonorgestrel and Ethinyl Estradiol in 84 pink active tablets containing 0.15 mg of Levonorgestrel, a synthetic progestogen and 0.03 mg Ethinyl Estradiol, and 7 white inert tablets.

As per IMS MATJune 2012 sales data, Seasonale tablets had annual US sales of around $81.2 million.

At the BSE, Lupin closed Thursday's trading at Rs.574, up 2.01 percent from the previous close.

by RTTNews Staff Writer

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