Ranbaxy Laboratories Ltd has announced that Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of the Company on May 18, 2007 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg, and 180 mg. Total annual market sales for Fexofenadine Hydrochloride Tablets were $931 million.
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 were 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 that is anticipated to 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 the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
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