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Lupin receives final approval for Blisovi 24 Fe Tablets

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From USFDA

Lupin announced that it has received final approval for its Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) from the United States Food and Drug Administration (FDA) to market a generic version of Warner Chilcott's Loestrin24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). Lupin's US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.

Lupin's Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) are the AB rated generic equivalent of Warner Chilcott's Loestrin24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

 

Loestrin24 Fe had US sales of USD 56.8 million (IMS MAT June 2015).

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First Published: Nov 03 2015 | 11:45 AM IST

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