HBW Insight 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

FDA Deems UVA Filter Ecamsule Eligible For Monograph, Seeks Data

This article was originally published in The Rose Sheet

Executive Summary

FDA's recent decision that the breakthrough UVA filtering ingredient ecamsule is "eligible for inclusion" in the OTC sunscreen drug monograph pending a safety and efficacy evaluation offers innovators more flexibility and could level the playing field among competing U.S. manufacturers

You may also be interested in...



PASS Reacts To Sunscreen TEA Denials: Has FDA ‘Moved The Goal Post’?

The Sunscreen Innovation Act may have served to clear FDA’s queue of pending sunscreen TEAs, but with denials across the board due to insufficient data, the Public Access to Sunscreens coalition questions the tenability of FDA’s standards and approach to review. The denial of L’Oreal’s TEA for ecamsule, an ingredient already available OTC through a new drug approval, only reinforces PASS’ view that FDA is resistant to working outside of the NDA pathway.

L'Oreal Seeks Monograph Inclusion Of Next-Gen Mexoryl UV Filter

L'Oreal has filed to have the second of its organic UV filters - drometrizole trisiloxane, marketed as Mexoryl XL - added to FDA's monograph for over-the-counter sunscreen drug products

L'Oreal Seeks Monograph Inclusion Of Next-Gen Mexoryl UV Filter

L'Oreal has filed to have the second of its organic UV filters - drometrizole trisiloxane, marketed as Mexoryl XL - added to FDA's monograph for over-the-counter sunscreen drug products

Related Content

UsernamePublicRestriction

Register

RS015659

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