Taro Pharmaceutical Industries Ltd. has received approval from the FDA for its Abbreviated New Drug Application (“ANDA”) for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg (“Cetirizine Tablets”). The product will be marketed by Taro’s U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc. Taro’s Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare’s Zyrtec® Allergy Tablets, 5 mg and 10 mg and Zyrtec® Hives Relief Tablets, 5 mg and 10 mg. Taro previously received approval for cetirizine hydrochloride oral solution in April 2008. Cetirizine Tablets are a nonprescription drug approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. Cetirizine Tablets are also approved for the relief of itching due to hives in adults and children 6 years of age and older. According to industry sources, annual U.S. sales of this product are approximately $350 million.
