Pink Sheet is part of the Business Intelligence Division 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

FDA on triclosan

This article was originally published in The Tan Sheet

Executive Summary

Agency solicits safety and efficacy data on .3% triclosan as an antigingivitis ingredient in dental pastes and oral rinses in a notice published in the July 6 Federal Register. FDA will review the data to determine if the ingredient can be generally recognized as safe and effective under the OTC oral health care drug products monograph. Comments will be accepted up to 90 days following publication of the notice. The review responds to a time and extent application filed by Ciba Specialty Chemicals last November (1"The Tan Sheet" Dec. 8, 2003, p. 8). Ciba stated that 3.5 bil. units of dental paste containing triclosan have been used in 13 selected countries over the past six years. Triclosan currently is marketed in the U.S. as an oral care ingredient through an NDA filed by Colgate-Palmolive...
Advertisement

Related Content

Triclosan Lacks Solo Use Data Needed To Join Gingivitis Monograph – Colgate
Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba
Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba

Topics

Advertisement
UsernamePublicRestriction

Register

PS097039

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