Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride

Tag : Date Syrup

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

Taro's cetirizine syrup is bioequivalent to McNeil ConsumerHealthcare's Zyrtec ® Syrup. Cetirizine syrup is a prescription medication used forthe relief of symptoms associated with perennial allergic rhinitisin children 6 to 23 months of age, and for chronic urticaria(hives) in children 6 months to 5 years of age. According toindustry sources, annual U.S. sales of cetirizine syrup productswere approximately $150 million.

Taro is a multinational, science-based pharmaceutical company,dedicated to meeting the needs of its customers through thediscovery, development, manufacturing and marketing of the highestquality 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 statementswithin the meaning of the Private Securities Litigation Reform Actof 1995, including statements regarding Taro's cetirizine syrupproducts. These statements include, but are not limited to,statements that do not describe historical facts and statementsthat refer or relate to events or circumstances the Company "plans"to happen, or similar language. Although Taro believes theexpectations reflected in such forward-looking statements to bebased on reasonable assumptions, it can give no assurance that itsexpectations will be attained. Factors that could cause actualresults to differ include industry and market conditions; slowerthan anticipated penetration of new markets; physician, pharmacistor patient acceptance of Taro's cetirizine syrup products and otherproducts; 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-lookingstatements speak only as of the date on which they are made. Taroundertakes no obligation to update, change or revise anyforward-looking statements, whether as a result of new information,additional or subsequent developments or otherwise.

http://www.taro.com