Triclosan
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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FDA on triclosan
Agency solicits safety and efficacy data on .3% triclosan as an antigingivitis ingredient in dental pastes and oral rinses in a notice slated to be published in the Federal Register July 6. FDA will review data to determine if ingredients can be generally recognized as safe and effective under the OTC oral health care drug products monograph. Comments will be accepted up to 90 days following publication of the notice. Triclosan review responds to a time and extent application filed by Ciba Specialty Chemicals last November. In the TEA, Ciba stated that 3.5 bil. units of dental paste containing triclosan have been used in 13 selected countries over the past six years (1"The Rose Sheet" Dec. 8, 2003, p. 5). Triclosan currently is marketed in the U.S. as an oral care ingredient through an NDA filed by Colgate-Palmolive...
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