HAWTHORNE, N.Y., Aug. 20, 2004 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) ("Taro") reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for loratadine syrup (oral suspension), 5 mg / 5 mL ("loratadine syrup"). The product will be marketed by Taro's U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.
Taro's loratadine syrup is bioequivalent to Schering's Claritin(R) syrup. Loratadine syrup is an over-the-counter medication used for the relief of symptoms due to seasonal allergic rhinitis. According to industry sources, U.S. sales of loratadine syrup products were approximately $15 million during the past 12 months.
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.
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 loratadine products. 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 loratadine products and other products; changes in Taro's financial position; regulatory actions; and, other risks detailed from time to time in the Taro's SEC reports, including its 2003 Annual Report 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.