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FreshBurst Listerine Study Must Exhibit 20% Gingivitis Reduction – FDA

This article was originally published in The Tan Sheet

Executive Summary

A six-month study of FreshBurst Listerine with Fluoride will need to show "a 20% reduction in gingivitis" over the control to receive agency approval, FDA told Pfizer execs at an Aug. 27 meeting

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Combination Oral Health Care Products Lack Sufficient Safety Data – J&J

Johnson & Johnson argues against including combination oral health care products in the OTC antingingivitis/antiplaque monograph in Nov. 25 comments to FDA

Combination Oral Health Care Products Safety Defended By Industry

Marketing of combination oral health care products should be permitted in the antigingivitis/antiplaque final monograph, according to the Joint Oral Care Task Group of the Consumer Healthcare Products Association and the Cosmetic, Toiletry and Fragrance Association. The group submitted comments to FDA on the subject Nov. 25

FreshBurst Listerine protocol

Pfizer proposes six-month, multi-center gingivitis study of 340 subjects at three clinical sites in Canada, Florida and Ohio for FreshBurst Listerine with Fluoride in Oct. 14 letter to FDA. Each center will have a principal investigator, who also may function as the site's clinical examiner. Pfizer originally had suggested a single-center study, which FDA opposed at an Aug. 27 feedback meeting (1"The Tan Sheet" Sept. 2, 2002, p. 14). Pfizer also agrees with FDA's suggestion to reduce the number of exclusion criteria. Pregnant women, diabetics, individuals with partial dentures or oral piercings are included under modified protocol, while those with "history of significant adverse events following use of oral hygiene products," "history of serious medical conditions" or alcoholism are excluded...

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