US regulator's approval for Lupin's heart disease drug

Mumbai, August 1 (IANS): 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.


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Title: US regulator's approval for Lupin's heart disease drug

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