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www.fdanews.com/articles/88614-ranbaxy-wins-tentative-approval-for-generic-zyrtec-syrup

RANBAXY WINS TENTATIVE APPROVAL FOR GENERIC ZYRTEC SYRUP

November 3, 2006

Ranbaxy Pharmaceuticals has received tentative approval from the FDA to manufacture and market generic cetirizine hydrochloride syrup, 5 mg/5 mL. The brand drug, Pfizer's Zyrtec Syrup, had total annual market sales $146.3 million in the year ending in June, Ranbaxy said, citing IMS Health.

The drug 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 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.

The drug 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, according to Ranbaxy.

"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," Jim Meehan, Ranbaxy's vice president of sales and marketing, said.