Pharmaceutical Business review

Ranbaxy receives final approval for allergy tablets

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 Zyrtec allergy tablets, 5mg and l0mg and Zyrtec hives relief tablets, 5mg and 10mg by Pfizer Pharmaceuticals.

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.

Jim Meehan, vice president of sales and distribution for Ohm Laboratories, a wholly owned subsidiary of Ranbaxy Laboratories, said: “This OTC product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade.”