Pink Sheet 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

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

This article was originally published in The Tan Sheet

Executive Summary

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).
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS088493

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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