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Taro Receives Approval For Metronidazole Topical Gel USP, 0.75 Percent ANDA |
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19 Jul 2006 |
HAWTHORNE, NY, USA | Jul 18, 2006 | 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 for Metronidazole Topical Gel USP, 0.75% ("metronidazole gel").
Taro's metronidazole gel, a prescription product used in the treatment of rosacea, is bioequivalent to MetroGel(R) Topical Gel, 0.75% of Galderma Laboratories, which had sales of approximately $2 million in the first quarter of 2006. The 0.75% and 1% strengths of MetroGel(R) had combined U.S. sales of more than $20 million in the first quarter of 2006.
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 metronidazole gel product. 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 consumer acceptance of Taro's metronidazole gel product; changes in the Company's financial position; new patents, regulatory actions, including patent and exclusivity decisions, 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.
SOURCE: Taro Pharmaceutical Industries Ltd. |
