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PDUFA Clock Ticks For FDA Decision On First OTC Acne Ingredient NDA

Executive Summary

Under PDUFA timelines for supplemental NDAs, FDA has until sometime in June to make a decision on Galderma Labs' application to switch its acne treatment adapalene, which would make it the first nonprescription product intended to do more than treat the condition at the surface of the skin. An FDA panel unanimously recommended allowing OTC status.

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