The Hindu Business Line : USFDA nod for Ranbaxy drug

Ranbaxy Laboratories has bagged final approval from the US Food and Drug Administration to manufacture and market Cetrizine Hydrochloride tablets of 5 mg and 10 mg. According to a company statement, the USFDA has determined the formulation to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Zyrtec allergy tablets and Zyrtec hives relief tablets by Pfizer Pharmaceuticals Inc. The total annual sale of Cetirizine Hydrochloride tablets, as a prescriptiononly product, was $1.3 billion, according to the IMSMAT, September 2007 data. Cetirizine Hydrochloride is indicated for 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. "We are pleased to receive this final approval for Cetirizine Hydrochloride tablets. This OTC product formulation further expands our portfolio of affordable generic alternatives, and will be launched immediately to all classes of trade," said Mr Jim Meehan, Vice President (sales and distribution), Ohm Laboratories Inc, a wholly owned subsidiary of Ranbaxy. - Our Bureau

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