Pharma company Lupin Thursday said the US health regulator has approved its marketing of 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 US 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 500mg and 1000mg strengths and as such will be entitled to 180 days of marketing exclusivity," it said.
Ranolazine Extended-release tablets are indicated for treatment of chronic angina.
According to IMS Health, the tablets posted sales of around $443.4 million in the US for 12 months ending March 2013.