Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has announced 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.