Drug major Lupin has received final approval from the US health regulator to market generic version of Warner Chilcott’s oral contraceptive Generess Fe in the American market.
In a BSE filing, Lupin said 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”, Lupin said in a BSE filing.
Quoting IMS MAT September 2015 sales data, Lupin said the tablets had US sales of USD 89.8 million.
The Mumbai-based firm has launched 9 products in the US market and received approvals for 20 products from the USFDA so far this fiscal.
The company added that its US subsidiary Lupin Pharmaceuticals Inc will commence promoting the product in the US shortly.
Lupin stock closed 0.17 per cent down at Rs 1,715.35 on BSE.