Healthcare Industry News:  Sanofi-aventis 

Biopharmaceuticals Generics FDA

 News Release - May 17, 2007

Ranbaxy Receives Tentative FDA Approval for Fexofenadine Hydrochloride Tablets

PRINCETON, N.J., May 17 (HSMN NewsFeed) -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market the antihistamine Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg, and 180 mg. Total annual market sales for Fexofenadine Hydrochloride Tablets were $931 million (IMS - MAT: March 2007).

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively are sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

"We are pleased to receive this tentative approval for Fexofenadine Hydrochloride Tablets. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA. This will further expand our product portfolio of affordable generic alternatives which have a favorable impact on the economics of the U.S. healthcare system," said Jim Meehan, Vice President of Sales and Marketing for RPI.

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 Limited, 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 over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.


Source: Ranbaxy Pharmaceuticals

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