Ranbaxy Laboratories has received final approval from the US 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).
USFDA has determined the Ohm formulation to be bio-equivalent 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 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).
Ohm, based in North Brunswick, USA, is a subsidiary of Ranbaxy Laboratories. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.