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Ranbaxy receives US FDA Approval for Valsartan

October 29, 2007

Ranbaxy Laboratories has received tentative approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market valsartan tablets, 40 mg, 80 mg, 160 mg and 320 mg. Total annual market sales for valsartan tablets were $1.3 billion (IMS MAT June 2007).

Valsartan is indicated for the treatment of hypertension alone or in combination with other anti-hypertensive agents. Valsartan is also indicated for the treatment of heart failure (NYHA class II -IV).

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