OTC drug "feedback" meeting
This article was originally published in The Tan Sheet
Warner-Lambert development and regulatory execs to meet with FDA on Oct. 8 at 10 a.m. in Rockville, Md. to discuss the regulatory pathway for producing a product that combines elements of the anticaries and oral health monographs. The firm presented a proposed testing protocol for a Listerine antiplaque/antigingivitis toothpaste before FDA's Dental Plaque Subcommittee last year (1"The Tan Sheet" June 1, 1998, p. 1)
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WARNER-LAMBERT LISTERINE ANTIPLAQUE/ANTIGINGIVITIS TOOTHPASTE approval would require a six-month clinical trial, FDA's Dental Plaque Subcommittee concluded following a Warner- Lambert presentation of a proposed testing protocol at its meeting in Gaithersburg, Md. May 27. The advisory group recommended that one additional clinical trial would be sufficient to establish the ingredient combination's safety and efficacy in the new dosage form. The Nonprescription Drugs Advisory Committee subgroup based its opinion on its prior determination that Listerine Antiseptic mouthwash's combination of essential oils - menthol, thymol, methyl salicylate and eucalyptol - is a safe and effective antiplaque and antigingivitis agent in concentrations of 51.7 mg/dose ("The Tan Sheet" Nov. 3, 1997, p. 4).
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