Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

OTC Benzocaine Needs Label Warning, Indication Change – Public Citizen

This article was originally published in The Tan Sheet

Executive Summary

In a citizen petition the group asks FDA to remove teething for children 2 years and older as an indication for some benzocaine products and require a label warning for OTC monograph benzocaine products concerning the risk of methemoglobinemia.

You may also be interested in...



Public Citizen Attempts To Force FDA Decision On Benzocaine Petition

FDA is sued by Public Citizen after failing to make a decision on a 2014 citizen petition urging the agency to remove an infant teething indication for OTC benzocaine products. The complaint asks a federal court to order a response from the agency within 30 days.

Public Citizen Attempts To Force FDA Decision On Benzocaine Petition

FDA is sued by Public Citizen after failing to make a decision on a 2014 citizen petition urging the agency to remove an infant teething indication for OTC benzocaine products. The complaint asks a federal court to order a response from the agency within 30 days.

OTC Hangover Remedy Safety On Tap For FDA Advisory Committees

CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107077

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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