HAWTHORNE, N.Y., Dec. 27, 2004 (PRIMEZONE) -- 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 ("ANDA") for Hydrocortisone Butyrate Ointment, 0.1%.
Taro's hydrocortisone butyrate ointment is bioequivalent to Ferndale Laboratories' Locoid(r) ointment. Hydrocortisone butyrate ointment is a prescription topical corticosteroid product used in managing inflammatory skin conditions. According to industry sources, U.S. sales of Locoid(r) ointment were approximately $3 million in the 12 months ending September 30, 2004.
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 2003 Annual Report 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.