Taro Receives FDA Approval for Imiquimod Cream, 5%

Generic Equivalent to Aldara® Cream, 5%

HAWTHORNE, N.Y.--(BUSINESS WIRE)-- Taro Pharmaceutical Industries Ltd. (“Taro,” or the “Company,” Pink Sheets: TAROF) reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (ANDA) for Imiquimod Cream, 5% (“imiquimod cream”).

Taro’s imiquimod cream is a prescription pharmaceutical product used for topical treatment of actinic keratosis and external genital warts and is bioequivalent to Aldara® Cream, 5% of Graceway Pharmaceuticals, LLC.

According to industry sources, imiquimod cream had annual sales of approximately $340 million in the U.S.

Aldara® is a registered trademark of Graceway Pharmaceuticals, LLC.

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 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, including statements regarding the Company’s imiquimod cream. 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; marketplace acceptance of Taro’s imiquimod cream; 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.


Taro Pharmaceutical Industries Ltd.
William J. Coote, 914-345-9001
VP and Treasurer
[email protected]

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