India’s biggest drugmaker, Ranbaxy Laboratories got final nod from the US food and drug administration to make and promote a respiratory allergy drug, Cetirizine hydrochloride oral solution (allergy) and children’s Cetirizine hydrochloride oral solution (Hives-Relief), 1 mg / mL (OTC).

The office of generic drugs, USFDA, has found out the Ohm formulation to be bioequivalent and have the same curative 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.

Cetirizine hydrochloride is prescribed for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes because of pollinosis or other upper respiratory allergies. Other indications include relief from itching due to hives (urticaria).

The total annual market sales for Cetirizine hydrochloride syrup as a prescription only product were USD 157 million (IMS-MAT: December 2007).

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

Ohm, based in North Brunswick, New Jersey, USA, is a wholly owned subsidiary of the company, which is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.

Shares of Ranbaxy, on Friday (April 25), gained Rs 3.5 to settle at Rs 478.8 on the Bombay Stock Exchange (BSE). The total volume of shares traded was 134,144 at the BSE (Friday).