Lupin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its 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) seasonale tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.
Lupin’s 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 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 is marketing its levonorgestrel and ethinyl estradiol tablets in 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Seasonale tablets had annual US sales of approximately $81.2 million.
EP News Bureau
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