HAWTHORNE, N.Y., April 22, 2008 (PRIME NEWSWIRE) -- Taro Pharmaceutical Industries Ltd. (Pink Sheets:TAROF) ("Taro", the "Company") reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg / 1 mL ("Cetirizine Oral Solution"). The product will be marketed by Taro's U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.
Taro's Cetirizine Oral Solution is bioequivalent to McNeil Consumer Healthcare's Zyrtec(r) Oral Solution. Cetirizine Oral Solution is an over-the-counter antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives. According to industry sources, annual U.S. sales of this product, when it was previously sold by prescription only, were approximately $160 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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Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Taro's Cetirizine Oral Solution product. Although Taro believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's Cetirizine Oral Solution product and other products; changes in Taro's financial position; regulatory actions; and, other risks detailed from time to time in Taro's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. Taro undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.