Healthcare Industry News:  Ambien  

Biopharmaceuticals Generics FDA

 News Release - April 26, 2007

Ranbaxy Receives Final Approval to Manufacture and Market Zolpidem Tablets for Insomnia

PRINCETON, N.J., April 26 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited (RLL), announced today that the Company has received final approval from the U.S. 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 formulation to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug AmbienĀ® Tablets 5mg and 10mg of Sanofi Aventis US, LLC. The product will be manufactured at the company's Ohm Laboratories Inc. facility, based in New Brunswick, New Jersey. Zolpidem Tartrate Tablets are indicated for the short- term treatment of insomnia, characterized by difficulty with sleep intervention. It has total annual market sales in the U.S. of $2.12 billion (IMS - MAT: December 2006).

"We are pleased to receive this final approval for Zolpidem Tartrate Tablets. This product will be launched immediately and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative for a molecule that has proven clinical value," said 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 9 countries.

*AmbienĀ® is a registered trademark of Sanofi Aventis

Source: Ranbaxy

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