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 has launched its Tri-Lo-Marzia tablets, an oral contraceptive drug, in the US market after getting approval from the American health regulator.
The Mumbai-based firm has launched nine products in the US the last fiscal and received approvals for 20 from the USFDA. Its cumulative abbreviated new drug application (ANDA) filings with the USFDA stood at over 220 with the company having received 131 approvals till date.