Ranbaxy Gets FDA Approval for Valsartan Tablets

India’s Ranbaxy Laboratories has received tentative approval from the FDA to market four dosage strenghs of valsartan, a generic version of Novartis’s hypertension drug Diovan.

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.

Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals, said: “We are pleased to receive tentative approval for Valsartan tablets. 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.”