FDA Deems UVA Filter Ecamsule Eligible For Monograph, Seeks Data
This article was originally published in The Rose Sheet
Executive SummaryFDA'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
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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.