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A “Precedent-Setting” OTC Switch – And A Case Study In Disregarding FDA’s Advice

This article was originally published in RPM Report

Executive Summary

Galderma’s OTC switch application for the acne therapy Differin (adapalene 0.1% gel) cleared an important milestone with a unanimous vote in favor of approval from an FDA advisory committee April 15. FDA urged the committee to consider the application as “precedent setting” given the theoretical risk of teratogenicity – but one committee member was more worried about the bad precedent of approving an application for a sponsor that didn’t do a label comprehension study they way FDA requested.

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