Lupin gets USFDA nod for heart disease drug
New Delhi: Drug major Lupin Thursday said it has received US health regulator`s approval to market generic version of Gilead Sciences, Inc`s Ranexa tablets, a drug used to treat heart disease, in the American market.
The company`s US-based subsidiary Lupin Pharmaceuticals, Inc has received final approval for its Ranolazine Extended- release tablets, 500 mg and 1000 mg from the United States Food and Drugs Administration (USFDA), Lupin Ltd said in a statement.
"Lupin believes that it is the first applicant to file an abbreviated new drug application (ANDA) for Ranexa Extended-release tablets 500 mg and 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity," it added.
Ranolazine Extended-release tablets are indicated for treatment of chronic angina. According to IMS Health data, the tablets posted sales of around USD 443.4 million in the US for the twelve months ending March, 2013.
Shares of Lupin today closed at Rs 871.55 apiece on the BSE, up 0.01 per cent from their previous close.