HAWTHORNE, N.Y.--(BUSINESS WIRE)--March 2, 2005--
Taro's 3-Day Treatment is Generic Equivalent to Monistat(R) 3
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 ("FDA") for its Abbreviated New Drug Application ("ANDA") for Miconazole 3 (Miconazole Nitrate Vaginal Cream, 4%), 3-Day Treatment ("Miconazole 3-Day Vaginal Cream").
Taro's Miconazole 3-Day Vaginal Cream is bioequivalent to McNeil-PPC, Inc.'s Monistat(R) 3. The product is a 3-day over-the-counter ("OTC") antifungal medication used for the local treatment of vulvovaginal candidiasis (yeast infections). According to industry sources, all forms of miconazole nitrate 3-day products had U.S. sales of approximately $50 million in 2004.
According to industry sources, the U.S. market for all OTC vaginal antifungal treatments was approximately $215 million in 2004. Taro manufactures an extensive line of store-brand vaginal antifungal creams, including clotrimazole and miconazole nitrate products in various strengths. Taro believes it is the only company with FDA approval to manufacture both clotrimazole and miconazole nitrate 3-day vaginal products for the U.S. market. In addition, Taro provides prescription vaginal antifungal products in the U.S.
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 Miconazole 3-Day Vaginal Cream and other vaginal 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 Miconazole 3-Day Vaginal 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.
CONTACT: Taro Pharmaceutical Industries Ltd.
Daniel Saks, 914-345-9000, ext. 6208
Kevin Connelly, 914-345-9000, ext. 6338
SOURCE: Taro Pharmaceutical Industries Ltd.