Pharma major, Lupin Ltd., announced that its subsidiary, Lupin Pharmaceuticals Inc. (LPI) has been granted final approval by the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market a generic version of Watson’s NOR-QD tablets. Lupin will commence shipping its norethindrone tablets, USP 0.35 mg shortly.
NOR-QD (norethindrone tablets, USP 0.35 mg) is a progestin-only oral contraceptive indicated for the prevention of pregnancy. Combined annual sales for NOR-QD and its generic equivalents were approximately $52 million for the twelve months ended June 2011 based on IMS Health sales data.
Commenting on the approval, Nilesh Gupta, group president and executive director, Lupin Limited said, “This ANDA approval from the US FDA marks Lupin’s foray into the US oral contraceptive market. We look forward to several more approvals and launches in the quarters and years to come.”