Pharma major, Lupin’s 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. The company 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.
Recently, Lupin Pharmaceutical Inc (LPI) had been granted final approval by the US Food and Drug Administration (FDA) for the company’s Abbreviated New Drug Application (ANDA) to market a generic version of UCB’s Keppra XR tablets.
