Drug maker Lupin today said it had received the final approval from the US health regulator to market generic version of Watson's Nor-QD tablets, an oral contraceptive, in the American market.
The company's US-based subsidiary, Lupin Pharmaceuticals Inc, has received the nod from US Food and Drug Administration (USFDA) to market generic norethindrone tablets in the strength of 0.35 mg, Lupin said in a statement.
Commenting on the development Lupin Group President and Executive Director Nilesh Gupta said: "This ANDA approval from the USFDA 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," Gupta added.
NOR-QD (norethindrone tablets, USP 0.35 mg) is a progestin-only oral contraceptive indicated for the prevention of pregnancy, the company said.
"Lupin will commence shipping its norethindrone tablets, USP 0.35 mg shortly," it said.
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According to IMS Health sales data for 12 months ended June 2011, the combined annual sales for NOR-QD and its generic equivalents were around $52 million.
Shares of Lupin today closed at Rs 483 on the Bombay Stock Exchange, up 2.12% from its previous close.