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New Delhi, Nov. 1 Ranbaxy Laboratories said it has received tentative approval from the US Food and Drug Administration to make and sell the hypertension tablets, Valsartan. The company is optimistic of its first-to-file application status, for the generic version of the Novartis drug sold under the brand name Diovan. If successful, a first-to-file application will grant it a six-month market exclusivity once Diovan goes off-patent in 2012.

The company has tentative approval for four strengths of the drug whose total annual market sales were $1.3 billion this year.

Valsartan is used in the treatment of hypertension, alone or in combination with other anti-hypertensive agents. “We believe, we are first-to-file a substantially complete ANDA and will stand to gain from the 180-day exclusivity available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives,” said Mr Jim Meehan, Vice-President of Sales and Distribution for Ranbaxy Pharmaceuticals Inc.

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Ranbaxy Laboratories Ltd

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