The Hindu Business Line : Ranbaxy gets US nod for respiratory allergy drug

New Delhi, April 25 Ranbaxy Laboratories Limited (RLL) has received the final approval from the US Food and Drug Administration to manufacture and market a respiratory allegery drug, cetirizine hydrochloride oral solution (allergy) and children’s cetirizine hydrochloride oral solution (hives-relief), 1 mg/mL (OTC).

The Office of Generic Drugs, US Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Children’s Zyrtec oral solution (allergy) and children’s Zyrtec oral solution (hives-relief), 1mg/mL of McNeil Consumer Healthcare. Total annual market sales for cetirizine hydrochloride syrup as a prescription only product were $157 million. Cetirizine hydrochloride is indicated for the temporary relief of running nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

“This product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade participating in the OTC private label market,” said Mr Jim Meehan, Vice-President of Sales and Distribution for Ohm Laboratories, USA, a wholly owned subsidiary company of Ranbaxy, in a statement.

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