Ranbaxy Laboratories Ltd (RLL), 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. 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 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 Jim Meehan, vice president of sales and distribution for RPI.
Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development.