HAWTHORNE, N.Y., April 24, 2006 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. and its affiliates and subsidiaries (Nasdaq:TARO) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Applications ("ANDA") for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg ("carvedilol tablets") and for Ondansetron Hydrochloride Tablets, equivalent to 4 mg, 8 mg and 24 mg ondansetron base respectively ("ondansetron tablets").
The tentative ANDA approvals for Taro's carvedilol tablets, received April 21, 2006, and ondansetron tablets, received earlier this month, are FDA determinations that Taro's ANDA submissions for these products currently satisfy the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and 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.
Carvedilol Tablets
The FDA has determined that Taro's carvedilol tablets are safe and effective for use when compared with the reference listed drug product, GlaxoSmithKline's Coreg(R) Tablets. Coreg(R) is a prescription product used in treating cardiovascular conditions, such as hypertension. According to industry sources, annual U.S. sales of Coreg(R) are approximately $1.1 billion. It is expected, as allowed under applicable law, that upon the March 2007 expiration of the patent covering the compound and its use in the treatment of hypertension, there will be generic competition for Coreg(R).
Ondansetron Tablets
The FDA has determined that Taro's ondansetron is safe and effective for use when compared with the reference listed drug product, Zofran(R) Tablets of GlaxoSmithKline in the same strengths. Ondansetron is a prescription pharmaceutical product used for the prevention of nausea and vomiting in patients undergoing chemotherapy and radiation therapy and in post-operative patients. According to industry sources, Zofran(R) Tablets have annual U.S. sales of approximately $600 million. In July 2005, Taro also received tentative approval for its ANDA for Ondansetron Hydrochloride Oral Solution.
Final Approval for Citalopram Hydrobromide Tablets
In March 2006, Taro received final approval from the FDA for its ANDA for Citalopram Hydrobromide Tablets, 10 mg, 20 mg and 40 mg ("citalopram tablets"). Taro's citalopram is bioequivalent to Forest Laboratories' Celexa(R) Tablets in the same strengths. Citalopram tablets are indicated for the treatment of depression. According to industry sources, annual U.S. sales of citalopram tablets are approximately $176 million.
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 carvedilol, ondansetron, and citalopram tablets. 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; physician, pharmacist or consumer acceptance of the Taro products discussed herein; changes in the Company's financial position; new patents, regulatory actions, including patent and exclusivity decisions, 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.