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Lupin Gets US Regulator's Nod to Market Oral Contraceptives

Drug major Lupin has received final approval from the US Food and Drug Administration (FDA) to market a generic version of Warner Chilcott's oral contraceptive Generess Fe in the American market.
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New Delhi: Drug major Lupin has received final approval from the US Food and Drug Administration (FDA) to market a generic version of Warner Chilcott's oral contraceptive Generess Fe in the American market.

Lupin said in a filing to the BSE that it "has received final approval for its Kaitlib Fe Tablets from the United States Food and Drug Administration (USFDA) to market Warner Chilcott's Generess Fe Chewable Tablets".

Quoting IMS MAT September 2015 sales data, Lupin said the tablets had US sales of $89.8 million.

The Mumbai-based firm has launched 9 products in the US market and received approvals for 20 products from the US health regulator so far this fiscal year.

The company added that its US subsidiary - Lupin Pharmaceuticals Inc - will commence promoting the product in the US shortly.

Shares in Lupin, on Friday, ended 0.33 per cent lower at Rs 1,712.70 apiece on the BSE, whose benchmark Sensex index finished up 0.33 per cent.

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