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Lupin gets USFDA’s approvals for generic Loestrin Fe 1/20 and Loestrin 1.5/30 tablets

24 Nov 2015 Evaluate

Pharma Major 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). The company’s US subsidiary, Lupin Pharmaceuticals Inc. shall commence promoting the product in the US shortly.

The company’s Blisovi Fe 1/20 Tablets 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.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.

 

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