Ranbaxy gets tentative approval for cetirizine syrup

Indian group Ranbaxy has received tentative approval from the US Food and Drug Administration to manufacture and market cetirizine HCl Syrup, 5mg/5ml. Total annual US market sales for this cetirizine formulation were $146.3 million, said the company, quoting IMS figures.

Cetirizine, originated by Belgian drugmaker UCB - which markets it as Zyrtec, 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 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 six months of age and older.