Ranbaxy gets tentative nod from USFDA for Cetirizine Syrup

New Delhi, Nov 3 (UNI) Ranbaxy Laboratories Ltd (RLL) today said it has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market 'Cetirizine Hydrochloride Syrup' in the US.

''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,'' Ranbaxy Pharmaceuticals Inc (RPI) VP (Sales and Marketing) Jim Meehan said.

The 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 between 2 years and above.

Total annual market sales for Cetirizine Hydrochloride Syrup were 146.3 million dollars as June 2006.

Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing and redness of the eyes.

It is also used in the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six months and older.

RPI based in Jacksonville, Florida, is a wholly-owned subsidiary of RLL and is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

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