Healthcare Industry News:  allergic rhinitis 

Biopharmaceuticals Generics FDA

 News Release - November 2, 2006

Ranbaxy Receives Tentative Approval to Manufacture and Market Cetirizine Hydrochloride Syrup

PRINCETON, N.J., Nov. 2 (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 Cetirizine Hydrochloride Syrup, 5 mg/5 ml. Total annual market sales for Cetirizine Hydrochloride Syrup were $146.3 million (IMS - MAT: June 2006).

Cetirizine Hydrochloride Syrup is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes. Cetirizine Hydrochloride Syrup is also indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Cetirizine Hydrochloride Syrup is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

"We are pleased to receive this tentative approval for Cetirizine Hydrochloride Syrup. This product represents a future opportunity for Ranbaxy and will be produced in our dedicated liquid manufacturing facility located in Gloversville, New York and will be launched following final approval from the FDA. This will further expand our product portfolio of affordable generic alternatives," according to 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 8 countries.


Source: Ranbaxy Pharmaceuticals

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