Taro Receives FDA Approval for Cetirizine Hydrochloride Tablets (OTC) ANDA

Monday, 27 July 2009 04:02

HAWTHORNE, N.Y.--Taro Pharmaceutical Industries Ltd. (“Taro,” the “Company,” Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration (“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.

Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at www.taro.com.

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