Lupin gets FDA approval for oral contraceptive

NEW DELHI: Pharma major Lupin Ltd announced on Tuesday 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.

NOR-QD® (norethindrone tablets) is a progestin-only oral contraceptive indicated for the prevention of pregnancy. "The combined annual sales for the generic are estimated around $52 million for the twelve months ended June 2011, based on IMS Health sales data," the company said in a filing to the stock exchanges.

Commenting on the approval, Nilesh Gupta, Group President and Executive Director, Lupin Ltd, 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.”

For the financial year ended March 2011, Lupin’s consolidated revenues and profit after tax were Rs 57,068 million ($1.28 billion) and Rs 8,626 million ($193 million), respectively.