Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

OTC drug "feedback" meeting

This article was originally published in The Tan Sheet

Executive Summary

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)

You may also be interested in...



Listerine toothpaste six-month clinical trial necessary for gingivitis claims -- FDA cmte.

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).

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Topics

UsernamePublicRestriction

Register

PS090390

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel