Lupin receives FDA approval for Generic Loestrin 24 Fe Tablets

25 November 2015 | News | By BioSpectrum Bureau

Lupin receives FDA approval for Generic Loestrin 24 Fe Tablets

Lupin's US subsidiary would commence promoting the product shortly in the US

Lupin's US subsidiary would commence promoting the product shortly in the US

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 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, 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.

Loestrin 24 Fe had US sales of $56.8 million (IMS MAT June 2015).

 

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