OTC "feedback" meeting
This article was originally published in The Rose Sheet
Executive Summary
Warner-Lambert scheduled to meet with FDA to discuss the regulatory pathway for producing a product that combines the anticaries and oral health monographs. The meeting will be held Oct. 8 at 10:00 a.m. in Rockville, Md. W-L presented a proposed testing protocol for a Listerine antiplaque/antigingivitis toothpaste before FDA's Dental Plaque Subcommittee last year (1"The Rose Sheet" June 1, 1998, p. 1)
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WARNER-LAMBERT LISTERINE TOOTHPASTE ANTIPLAQUE/ANTIGINGIVITIS INDICATIONS would require a six-month study in humans, FDA's Nonprescription Drugs Advisory Committee's Dental Plaque Subcommittee concluded following a Warner-Lambert presentation on a proposed testing protocol. Based on the subcommittee's prior conclusion that Listerine Antiseptic Mouthwash's essential oil combination -- menthol, thymol, methyl salicylate and eucalyptol -- is a safe and effective antiplaque and antigingivitis agent in concentrations of 51.7 mg/dose ("The Rose Sheet" Nov. 3, 1997, p. 16), the NDAC group determined at its May 27 meeting that one additional trial in humans would be sufficient to establish the ingredient combination's safety and efficacy in a new toothpaste dosage form.
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