Listerine With Fluoride Development Continues With “Feedback” Meeting
This article was originally published in The Rose Sheet
Executive Summary
Pfizer Consumer Healthcare plans to conduct a six-month clinical study involving at least 300 subjects to determine whether adding .02% sodium fluoride to the company's Listerine mouthrinse affects the antiplaque/ antigingivitis effectiveness of the productYou may also be interested in...
FreshBurst Listerine Study Must Exhibit 20% Gingivitis Reduction – FDA
A six-month study of FreshBurst Listerine with Fluoride will need to show "a 20% reduction in gingivitis" over a control to merit agency sign-off, FDA told Pfizer execs at an OTC "feedback" meeting Aug. 27
FreshBurst Listerine Study Must Exhibit 20% Gingivitis Reduction – FDA
A six-month study of FreshBurst Listerine with Fluoride will need to show "a 20% reduction in gingivitis" over a control to merit agency sign-off, FDA told Pfizer execs at an OTC "feedback" meeting Aug. 27
Listerine with fluoride meeting postponed
"Feedback" meeting on OTC anticaries drug products monograph slated for June 18 in Rockville, MD will be rescheduled, probably within a month, according to FDA's division of OTC Drug Products. Meeting is part of Pfizer's efforts to amend the monograph to allow a mouthrinse combining essential oils and sodium fluoride (1'The Rose Sheet" June 10, 2002, p. 5). FDA says it needs more time to review relevant materials...
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