JACKSONVILLE, Fla., Nov. 2 (UPI) -- Ranbaxy said Thursday it has won tentative U.S. approval for allergy drug cetirizine hydrochloride syrup, 5 mg/5 ml.
The product 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.
The new product is a generic version of Belgium-based UCB's Zyrtec.
Ranbaxy, a subsidiary of India-based drug maker Ranbaxy Laboratories, said total sales of cetirizine hydrochloride syrup were $146.3 million ast of June 2006, quoting data from IMS Health.
Tentative approval from the Food and Drug Administration means the company must work out details unrelated to the drug's safety and efficacy such as labeling, before it can secure final approval.
