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FreshBurst Listerine protocol

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Pfizer's proposed six-month, multi-center, 340-person gingivitis study in recent letter, noting if the trial determines "Listerine with fluoride is as effective as Listerine in reducing gingivitis and plaque," agency likely will grant the sodium fluoride/essential oils combination monograph status. FDA says it "will explore regulatory mechanisms for interim marketing under the OTC drug monograph procedures at [that] time." Pfizer modified its study proposal in October after an FDA feedback meeting (1"The Tan Sheet" Nov. 18, 2002, In Brief)...
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