FDA nod for Lupin's new generic

November 03, 2015 | Tuesday | News | By BioSpectrum Bureau

FDA nod for Lupin's new generic

Lupin's Blisovi 24 Fe Tablets are the AB rated generic equivalent of Warner Chilcott's Loestrin 24 Fe Tablets

Lupin's Blisovi 24 Fe Tablets are the AB rated generic equivalent of Warner Chilcott's Loestrin 24 Fe Tablets

Pharma Major Lupin has 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 (US FDA) to market a generic version of Warner Chilcott's Loestrin 24 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 Loestrin 24 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.

Loestrin 4 Fe had US sales of $56.8 million (IMS MAT June 2015).

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