Drug major Lupin 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 (US FDA), 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 $443.4 million in the US for the twelve months ending March, 2013.
