Lupin gets USFDA nod for generic Seasonique tablets
New Delhi: Drug major Lupin Friday said it has received US health regulator's approval for 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 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 USD 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 USD 5 billion and growing at around 8 percent annually.
Shares of Lupin Friday closed at Rs 659.65 on the BSE, up 2.29 percent from their previous close.