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This article was originally published in The Rose Sheet

Executive Summary

Colgate-Palmolive requests 45 day extension to FDA's deadline for submitting safety and efficacy data on triclosan as an antigingivitis ingredient in dental pastes and oral rinses. Deadline was originally set for Oct. 4, but Colgate requests that date be postponed until Nov. 18 in a Sept. 17 letter to the agency. Additional time will allow Colgate the opportunity to evaluate efficacy data on products formulated with triclosan in the U.S. and abroad in regard to the new time and extent application procedures, Colgate says, noting by extending the deadline, FDA will permit the company to prepare a comprehensive submission. FDA issued a call for data on .3% triclosan in July to determine if the ingredient should be considered safe and effective under the OTC Oral Health Care Products Monograph (1"The Rose Sheet" July 5, 2004, In Brief)...

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