Ranbaxy Laboratories Ltd has received final approval from US Food and Drug Administration (FDA) 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, 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 runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies. Other indications include relief from itching due to hives (urticaria).
"We are pleased to receive this final approval for cetirizine hydrochloride oral solution that has proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions as an over-the-counter product. This product formulation further expands the portfolio of affordable generic alternatives and will be launched immediately to all classes of trade participating in the OTC private label market, "said Jim Mechan, Vice President of Sales and Distribution for Ohm Laboratories, USA, a wholly owned subsidiary Company of Ranbaxy.
Ohm, based in North Brunswick, New Jersey, USA, is a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLI.), India's largest pharmaceutical Company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.