HAWTHORNE, N.Y., Aug. 5, 2005 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Halobetasol Propionate Cream, 0.05% ("halobetasol cream").
Taro's halobetasol cream is bioequivalent to Bristol-Myers Squibb's Ultravate(r) cream. Halobetasol cream is a super-high potency prescription topical corticosteroid product used primarily for the treatment of inflammatory skin conditions. According to industry sources, U.S. sales of halobetasol cream products were approximately $24.7 million in 2004.
Taro also markets Halobetasol Propionate Ointment, 0.05%.
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 more information, please visit 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 halobetasol 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 halobetasol 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.