Ranbaxy obtains FDA approval for cetirizine hydrochloride oral solution

The Office of Generic Drugs, FDA, 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. Ohm Laboratories will market the formulation in the OTC private label market.

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).

Jim Meehan, vice president of sales and distribution for Ohm Laboratories, USA, a wholly owned subsidiary company of Ranbaxy, said: “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.”