2005 Taro News Archive

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August 4, 2005

Taro Receives Approval for Hydrocortisone Butyrate Cream USP, 0.1% ANDA; Generic Equivalent to Locoid® Cream

HAWTHORNE, N.Y., Aug 04, 2005 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Hydrocortisone Butyrate Cream USP, 0.1% ("hydrocortisone butyrate cream").

Taro's hydrocortisone butyrate cream is bioequivalent to Ferndale Laboratories' Locoid(R) cream. Hydrocortisone butyrate cream is a prescription topical corticosteroid product used in managing inflammatory skin conditions. According to industry sources, U.S. sales of Locoid(R) cream were approximately $8.2 million in 2004. Taro also markets hydrocortisone butyrate ointment and topical solution products.

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 Company's hydrocortisone butyrate 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 hydrocortisone butyrate 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 Annual Reports 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.

SOURCE: Taro Pharmaceutical Industries Ltd.

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