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Taro Receives Tentative Approval for Ranitidine Syrup ANDA |
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27 Feb 2007 |
Generic Equivalent of Zantac(R) Syrup
HAWTHORNE, NY, USA | Feb 26, 2007 | Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application for Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL ("ranitidine syrup").
Ranitidine syrup is a prescription product used for the treatment of ulcers, gastroesophageal reflux disease, or GERD, and other gastro-intestinal disorders. The FDA has determined that Taro's ranitidine syrup is safe and effective for use when compared with the reference listed drug product, GlaxoSmithKline's Zantac(R) Syrup, 15 mg/mL.
The tentative ANDA approval for Taro's ranitidine 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 (currently expected to occur during May 2009), 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, Zantac(R) Syrup has annual U.S. sales of approximately $125 million. It is expected that when Taro receives final FDA approval of its ANDA, there will be additional generic competition for Zantac(R) Syrup.
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, please visit 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 ranitidine syrup product. 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 failure to receive final approval for Taro's ANDA submission for ranitidine syrup; the granting of additional exclusivities or restrictions to Zantac(R) Syrup; industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro's ranitidine syrup; 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.
CONTACT: Taro Pharmaceutical Industries Ltd.
Daniel Saks, Vice President, Corporate Affairs
914-345-9000 ext. 6208
SOURCE: Taro Pharmaceutical Industries Ltd |
