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Lupin gets USFDA nod for generic oral contraceptive tablets

Lupin gets USFDA nod for generic oral contraceptive tablets

New Delhi, Nov 24 : Lupin today said it has received US health regulator’s final approval to market Blisovi oral contraceptive tablets in different strengths in the American market.

“The company has received final approvals from the United States Food and Drug Administration (USFDA) to market generic versions of Warner Chilcott’s Loestrin Fe 1/20 tablets and Loestrin Fe 1.5/30 tablets”, Lupin said in a statement.

Lupin’s US subsidiary, Lupin Pharmaceuticals Inc shall commence promoting the product in the US shortly, it added.

Pharma Major Lupin Limited (Lupin) has said it 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) 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 Inc. shall commence promoting the product in the US shortly.

Lupin’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.

According to IMS MAT data, Loestrin Fe 1/20 had US sales of USD 139.7 million while Loestrin Fe 1.5/30 had sales of USD 55.5 million.

 

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