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14.04.2005 13:01:00
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Taro Receives Approval for Ciclopirox Olamine Cream USP, 0.77% ANDA
Taro Receives Approval for Ciclopirox Olamine Cream USP, 0.77% ANDA Generic Equivalent to Loprox(R) Topical Cream
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 Ciclopirox Olamine Cream USP, 0.77% ("ciclopirox cream").
Taro's ciclopirox cream is a prescription pharmaceutical product used for the treatment of fungal infections of the skin. The Taro product is bioequivalent to Medicis Pharmaceutical Corp.'s Loprox(R) Topical Cream. According to industry sources, ciclopirox cream products had U.S. sales of approximately $32.5 million in 2004.
Taro and its subsidiaries manufacture and market a broad line of prescription and over-the-counter antifungal 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 introduction of the Company's ciclopirox cream and other antifungal 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 ciclopirox cream and other antifungal 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.
--30--ML/ny*
Pharmaceutical Writers/Business Editors
HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 14, 2005--
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 Ciclopirox Olamine Cream USP, 0.77% ("ciclopirox cream").
Taro's ciclopirox cream is a prescription pharmaceutical product used for the treatment of fungal infections of the skin. The Taro product is bioequivalent to Medicis Pharmaceutical Corp.'s Loprox(R) Topical Cream. According to industry sources, ciclopirox cream products had U.S. sales of approximately $32.5 million in 2004.
Taro and its subsidiaries manufacture and market a broad line of prescription and over-the-counter antifungal 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 introduction of the Company's ciclopirox cream and other antifungal 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 ciclopirox cream and other antifungal 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.
--30--ML/ny*
CONTACT: Taro Pharmaceutical Industries Ltd. Daniel Saks, 914-345-9000 ext. 6208 or Kevin Connelly, 914-345-9000 ext. 6338
KEYWORD: NEW YORK INDUSTRY KEYWORD: MEDICAL BANKING PHARMACEUTICAL CONSUMER/HOUSEHOLD PRODUCT SOURCE: Taro Pharmaceutical Industries Ltd.
Copyright Business Wire 2005
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