Ranbaxy USFDA approval for Valsartan Tablets

Ranbaxy Laboratories Ltd on October 29, 2007 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration 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).

"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 exclusively 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 Jim Meehan, Vice President of Sales and Distribution for RPL.

Ranbaxy Pharmaceuticals Inc (RH) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), India's largest pharmaceutical Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.