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Tuesday, Oct 26, 2004

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Ranbaxy gets FDA nod

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NEW DELHI: Ranbaxy Laboratories Ltd has received tentative approval from the US Food and Drug Administration to manufacture and market Carvedilol tablets used for treatment of cardiac disorders.

Carvedilol tablets are indicated for treatment of congestive heart failure, left ventricular dysfunction following myocardial infarction and hypertension.

The company has received tentative approval for 3.125 mg, 6.25 mg, 12.5 mg and 25 mg tablets and the total market sales for Carvedilol tablets were $729 million.

According to Mr Jim Meehan, Vice-President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc (RPI) of the US, "this tentative approval will provide an opportunity to expand our cardiovascular basket of generic products at the time of final approval when granted by the USFDA, thereby, adding depth and breadth to our overall generic product offerings that will be of a benefit to the US healthcare system."

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