Lupin gets FDA nod for oral contraceptive drug

PTI Updated - April 12, 2013 at 06:57 PM.

Drug major Lupin today said it has received US health regulator’s approval for the generic version of Teva Branded Pharm’s Seasonique tablets, used to prevent pregnancy, in the American market.

Lupin Pharmaceuticals Inc, a subsidiary of Lupin Ltd, has received final approval from the US Food and Drug Administration (USFDA) for its DayseeTM tablets, Lupin Ltd said in a statement.

The Mumbai-headquartered firm said it has already commenced shipping the product, indicated for use by women to prevent pregnancy, to the US market.

According to IMS MAT Dec 2012 sales data, the total branded and generic sales of the product stood at $161 million.

With the current approval, the company has now received 11 approvals in oral contraceptives (OC) segment in the US market.

The OC market in the US is valued at around $5 billion and growing at around 8 per cent annually.

Shares of Lupin today closed at Rs 659.65 on the BSE, up 2.29 per cent from their previous close.

Published on April 12, 2013 13:27