Business Editors/Health/Medical Writers
HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 7, 2004
Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for terconazole vaginal cream, 0.8%.
Taro's terconazole vaginal cream, 0.8% is bioequivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 3 Vaginal Cream 0.8%. Terconazole cream is a prescription antifungal medication used for the local treatment of vulvovaginal candidiasis (yeast infections). According to industry sources, the Ortho-McNeil product had U.S. sales of $27.5 million in 2003.
"Taro has developed a range of generic antifungal pharmaceutical products since 1993," said Barrie Levitt, M.D., Chairman of the Company. "In addition, we have been an innovator in this category with the FDA approval of Taro's New Drug Application ("NDA") for our Clotrimazole 3-Day Vaginal Cream product."
Currently, Taro has 32 filings at the FDA: 31 ANDAs, including tentative approvals for fluconazole tablets and loratadine syrup, plus an NDA related to the Company's proprietary NonSpil(TM) liquid drug delivery system. In addition, the Company has 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.
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 introduction of the Company's terconazole vaginal cream product and other Taro 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 terconazole vaginal cream product and other antifungal products; 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 2002 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.
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