HAWTHORNE, N.Y., July 29, 2004 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that its U.S. affiliate has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for fluconazole tablets in four strengths: 50 mg, 100 mg, 150 mg and 200 mg.
Taro's fluconazole tablets are bioequivalent to Pfizer's Diflucan(R) tablets. Fluconazole tablets are a prescription antifungal product used for the treatment of candidiasis (yeast infections) affecting various parts of the body, as well as for treating cryptococcal meningitis. According to industry sources, U.S. sales of Diflucan(R) tablets were approximately $480 million in 2003. In November 2003, Taro received tentative approval from the FDA for its ANDA for fluconazole tablets.
"In addition to manufacturing the finished product, Taro will manufacture the active pharmaceutical ingredient for fluconazole tablets," said Barrie Levitt, M.D., Chairman of the Company. "Taro's fluconazole tablets extend our wide range of antifungal products in both oral and topical dosage forms."
Currently, Taro has 30 filings at the FDA: 29 ANDAs, including one tentative approval, and a New Drug Application related to the Company's NonSpil(TM) liquid drug delivery system. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries.
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 the Company's fluconazole and other antifungal 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; physician, pharmacist or patient acceptance of Taro's fluconazole products and other antifungal products; changes in Taro's manufacture of fluconazole; 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 2003 Annual Report 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.