HAWTHORNE, N.Y.--(BUSINESS WIRE)--Nov. 12, 2003--Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS: TARO) reported today that its U.S. affiliate has received tentative 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, 2002 U.S. sales of Diflucan(R) tablets were approximately $423 million. Taro will also manufacture the active pharmaceutical ingredient for its fluconazole tablets.

A tentative approval is an FDA determination that an ANDA submission currently satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed exclusivities and restrictions. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.

"Taro's fluconazole tablets extend our wide range of antifungal products in both oral and topical dosage forms," said Barrie Levitt, M.D., Chairman of the Company.

Additional Topical Approvals

Earlier this month, Taro received approval from the FDA for its ANDA for fluorouracil topical solution in 2% and 5% strengths. These products are bioequivalent to ICN Pharmaceuticals' Efudex(R) Topical Solution and are used in the treatment of actinic keratosis and superficial basal cell carcinoma (in addition to other indications). According to industry sources, 2002 U.S. sales of these products were approximately $700,000.

Currently, Taro has 32 filings at the FDA: 31 ANDAs, including two tentative approvals and three unique supplemental ANDAs, plus 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 around the world.

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. 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. Such forward- looking statements may include, but are not limited to, statements regarding production and marketing of Taro's fluconazole tablets and fluorouracil solution products. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, marketplace acceptance of Taro's fluconazole tablets and fluorouracil solution products, the future size of the markets for these product, 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.

    CONTACT: Taro Pharmaceutical Industries Ltd.
             Daniel Saks, 914-345-9000 ext. 6208
              or
             Kevin Connelly, 914-345-9000 ext. 6338

    SOURCE: Taro Pharmaceutical Industries Ltd.