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M2 PHARMA-September 20, 2011-Lupin gains final FDA nod for generic version of Watson's NOR-QD tablets(C)2011 M2 COMMUNICATIONS
20 September 2011 - India's Lupin Ltd (BOM:600257) said today that its Lupin Pharmaceuticals Inc subsidiary has obtained final US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Watson's (NYSE:WPI) NOR-QD tablets (norethindrone tablets, USP 0.
NOR-QD is a progestin-only oral contraceptive indicated for the prevention of pregnancy.
The company received approval in April 2010 for Heather tablets, their generic version of Watson s Nor-QD tablets and the received approval for Norethindrone Acetate 5mg tablets on Thursday.