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Terconazole

Terconazole is an anti-fungal medication, primarily used to treat vaginal fungal infections.

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Taro Receives Approval for Terconazole Vaginal Cream, 0.4% ANDA; Generic Equivalent to Terazol-R- 7 Vaginal Cream
From Business Wire, 1/20/05

HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) and its affiliates and subsidiaries ("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 terconazole vaginal cream, 0.4%.

Taro's terconazole vaginal cream, 0.4% is bioequivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 7 Vaginal Cream 0.4%. Terconazole vaginal 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 approximately $42 million for the 12 months ending September 30, 2004.

In April 2004, Taro also received FDA approval of its ANDA for terconazole vaginal cream, 0.8%, bioequivalent to Ortho-McNeil Pharmaceutical's Terazol(R) 3 Vaginal Cream 0.8%.

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, 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 introduction of the Company's terconazole vaginal cream 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 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 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.

COPYRIGHT 2005 Business Wire
COPYRIGHT 2005 Gale Group

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