Ranbaxy Laboratories Limited (RLL) has received tentative approval from the US 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, a Ranbaxy press release said.
"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, USA.