Ranbaxy Laboratories Receives Tentative FDA Approval to Manufacture and Market Zolpidem Tablets
PRINCETON, N.J., March 16 /PRNewswire-FirstCall/ -- Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien(R) Tablets 5mg and 10mg of Sanofi Aventis US, LLC. The products will be manufactured at the company's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey. Total annual market sales for Zolpidem Tartrate Tablets were USD 2.12 Bn (IMS: Dec. 2006).
Zolpidem Tartrate Tablets are indicated for the short-term treatment of insomnia and related disorders.
"We are pleased to receive this tentative approval for Zolpidem Tartrate Tablets. This product will be launched following final approval from the FDA and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative," according to Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc..
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (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.
Ranbaxy Laboratories Ltd., headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. 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. The company is serving its customers in more than 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in nine countries.
CONTACTS: Charles M. Caprariello Vice President, Corporate Communications Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder Partners Inc. (212) 994-7517 Anuj Baveja RF Binder Partners Inc. (212) 994-7552
Ranbaxy Pharmaceuticals Inc.CONTACT: Charles M. Caprariello, Vice President, Corporate Communications,Ranbaxy Inc., +1-609-720-5615; Edwige Buteau, RF Binder Partners Inc.,+1-212-994-7517; Anuj Baveja, RF Binder Partners Inc., +1-212-994-7552
Web site: http://www.ranbaxy.com/