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 USD 443.4 million in the US for 12 months ending March 2013.
--IANS (Posted on 01-08-2013)