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

Vasoconstrictor Pupil Dilation Warning Established In Final Rule

This article was originally published in The Tan Sheet

Executive Summary

A pupil dilation warning on both single- and combination-ingredient OTC vasoconstrictor eyedrops will be required by FDA despite previous objections from industry.

You may also be interested in...



Combo OTC Drug Labeling Deadlines To Be Addressed In Final Monographs

FDA will take into account OTC labeling reg compliance deadlines when publishing final monographs that could subject combination products to frequent relabeling, the agency says in a June 20 Federal Register notice extending by one year implementation provisions for specific types of OTCs.

Combo OTC Drug Labeling Deadlines To Be Addressed In Final Monographs

FDA will take into account OTC labeling reg compliance deadlines when publishing final monographs that could subject combination products to frequent relabeling, the agency says in a June 20 Federal Register notice extending by one year implementation provisions for specific types of OTCs.

Vasoconstrictor warning "not appropriate" for single ingredient products -- NDMA.

VASOCONSTRICTOR WARNING "NOT APPROPRIATE" FOR MONOGRAPH OTCs, NDMA maintains in May 26 comments on FDA's Feb. 23 proposed label warning on vasoconstrictors regarding the possibility of pupil dilation. The Nonprescription Drug Manufacturers Association opposes the warning on single ingredient monograph products, arguing the agency proposal is based on adverse drug experiences (ADEs) for three Rx-to-OTC switch products that contain both a vasoconstrictor and pheniramine maleate, an antihistamine. "The market experience with single ingredient ophthalmic vasoconstrictor products does not demonstrate the same pattern of adverse experience reports and does not warrant FDA's current action," NDMA says.

Related Content

Topics

UsernamePublicRestriction

Register

PS091362

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