HAWTHORNE, N.Y., Nov. 8, 2006 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. ("Taro," the "Company,") (Nasdaq: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 Meloxicam Tablets, 7.5 mg and 15 mg ("meloxicam tablets").
Taro's meloxicam tablets are used for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. This new Taro prescription product is bioequivalent to Boehringer Ingelheim's Mobic(r) Tablets. According to industry sources, branded and generic meloxicam tablet products had U.S. sales of approximately $105 million in the third quarter of 2006.
Tentative Approval of Cetirizine Syrup in the U.S.
Taro also reported today that it has received tentative approval from the FDA for its Abbreviated New Drug Application ("ANDA") for Cetirizine Hydrochloride Syrup, 1 mg/mL ("cetirizine syrup").
The FDA has determined that Taro's cetirizine syrup is safe and effective for use when compared with the reference listed drug product, Zyrtec(r) Syrup of Pfizer, Inc. Zyrtec(r) Syrup is a prescription product used for treating allergic rhinitis and chronic urticaria (hives). The tentative ANDA approval for Taro's cetirizine syrup is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions, or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. According to industry sources, annual U.S. sales of Zyrtec(r) Syrup are approximately $153 million. It is expected that, upon the December 2007 expiration of the pediatric exclusivity covering Zyrtec(r) Syrup, as allowed under applicable law, there will be additional generic competition for Zyrtec(r).
Taro Pharmaceutical Industries Ltd. 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 the Company's meloxicam tablets and cetirizine syrup products. Although Taro Pharmaceutical Industries Ltd. 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; marketplace acceptance of the new Taro meloxicam tablets and cetirizine syrup products; delays in receipt of a final approval for the cetirizine syrup product; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company'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. The Company 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.