Taro 2002 News Archive

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5/31/2002

Taro Pharmaceuticals Receives FDA Approval for Amcinonide Cream USP, 0.1%

Hawthorne, New York, May 31, 2002 - Taro Pharmaceutical Industries Ltd. (NASDAQ/NMS: TARO) reported today that the Company has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Amcinonide Cream USP, 0.1%.

Taro’s Amcinonide Cream USP, 0.1% is bioequivalent to Fujisawa Healthcare’s Cyclocort® Topical Cream. Amcinonide Cream is a prescription, high-potency topical corticosteroid used primarily in managing inflammatory skin conditions.

Taro believes it is the first company to receive approval to market a generic equivalent to Cyclocort® Topical Cream in the U.S. According to industry sources, the U.S. market for Cyclocort® Topical Cream was $5.4 million in 2001. The new Taro product, which is manufactured in Taro’s facilities in Israel, is available for immediate shipment.

"Amcinonide Cream broadens Taro’s line of topical corticosteroids, providing additional options for doctors, pharmacists and patients who seek affordable, high-quality generic alternatives to branded drugs," said Barrie Levitt, M.D., Chairman of the Company. "Amcinonide is the latest product for which Taro manufactures the active pharmaceutical ingredient as well as the finished dosage form."

Taro currently has 14 filings submitted to the FDA, and multiple international filings with regulatory agencies 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.

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. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, 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 Prospectus dated October 1, 2001 and its Annual Report on Form 20-F.