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

W-L FreshBurst Listerine Expanded Anticaries Clinical Test Urged By FDA

This article was originally published in The Tan Sheet

Executive Summary

Potential changes to the anticaries and antiplaque/antigingivitis monographs to allow a crossover product must be accompanied by stronger clinical studies than proposed by Warner-Lambert for FreshBurst Listerine With Fluoride, FDA advised the company at an OTC drug "feedback" meeting in Rockville, Md. June 6.

You may also be interested in...



W-L Listerine Anticaries Rinse Gingivitis Assessment Required - FDA

Acceptance of plaque reduction as the sole outcome of an experimental gingivitis model conducted to demonstrate the antiplaque/antigingivitis activities of Pfizer/Warner-Lambert's Listerine anticaries mouthrinse would be "premature," FDA tells company.

W-L Listerine Anticaries Rinse Gingivitis Assessment Required - FDA

Acceptance of plaque reduction as the sole outcome of an experimental gingivitis model conducted to demonstrate the antiplaque/antigingivitis activities of Pfizer/Warner-Lambert's Listerine anticaries mouthrinse would be "premature," FDA tells company.

W-L Listerine Anticaries Fluoride Rinse Formula Change Proposed To FDA

Warner-Lambert has changed its proposed fluoride-containing oral anticaries/antiplaque/antigingivitis rinse to a .02% sodium fluoride formula to reflect results from recently conducted market research on taste, the company says in comments submitted to FDA May 15.

Related Content

Topics

UsernamePublicRestriction

Register

PS091317

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