Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Jun 2008 - 1:00 PDT

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Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF, "Taro", the "Company") reported that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for prescription Cetirizine Hydrochloride Syrup, 1 mg / 1 mL ("cetirizine syrup"). Taro had received tentative approval for this ANDA in October 2007. The Company plans to market the product through its U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.

Taro's cetirizine syrup is bioequivalent to McNeil Consumer Healthcare's Zyrtec® Syrup. Cetirizine syrup is a prescription medication used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age, and for chronic urticaria (hives) in children 6 months to 5 years of age. According to industry sources, annual U.S. sales of cetirizine syrup products were approximately $150 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 http://www.taro.com.

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 syrup products. These statements include, but are not limited to, statements that do not describe historical facts and statements that refer or relate to events or circumstances the Company "plans" to happen, or similar language. 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 syrup products 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.

http://www.taro.com