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Lupin receives FDA approvals for generic loestrin tabs

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The tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception

Lupin has received final approvals for its blisovi Fe 1/20 tablets (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets, 75 mg) and blisovi 1.5/30 tablets (norethindrone acetate and ethinyl estradiol tablets usp, 1.5 mg/0.03 mg and ferrous fumarate tablets, 75 mg) from the United States Food and Drug Administration (FDA) to market generic versions of Warner Chilcott’s loestrin Fe 1/20 tablets (norethindrone acetate and ethinyl estradiol tablets usp, 1 mg/0.02 mg and ferrous fumarate tablets, 75 mg) and loestrin Fe 1.5/30 tablets (norethindrone acetate and ethinyl estradiol tablets usp, 1.5 mg/0.03 mg and ferrous fumarate tablets, 75 mg). Lupin’s US subsidiary, Lupin Pharmaceuticals shall commence promoting the product in the US shortly.

Lupin’s Blisovi Fe 1/20 ablets and Blisovi 1.5/30 tablets are the AB rated generic equivalent of Warner Chilcott’s Loestrin Fe 1/20 tablets and Loestrin Fe 1.5/30 tablets and are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Loestrin Fe 1/20 had US sales of $ 139.7 million while Loestrin Fe 1.5/30 had US sales of $ 55.5 million.

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