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Tentative Approval Granted to Manufacture and Market Zolpidem, Generic Version of Ambien

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..

Source: Ranbaxy Laboratories Limited

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