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Allergies
Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
May 11th, 2008
Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC). The Office of Generic Drugs, U.S. 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...
Source: Pharma Investments, Ventures & Law Weekly (2008-05-11)
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