Ranbaxy gets USFDA nod for Valsartan tablets
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market valsartan tablets, 40 mg, 80 mg, 160 mg and 320 mg.
Valsartan is indicated for the treatment of hypertension alone or in combination with other anti-hypertensive agents. It is also indicated for the treatment of heart failure.
Total annual sales of Valsartan tablets was $1.3 billion as at June 2007.
"Ranbaxy was the first to file a substantially complete ANDA and will stand to gain from the 180-day exclusively available to the first filer," Jim Meehan, vice president of sales of Ranbaxy, said.
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