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

 
• By Malcolm Spicer

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.

Galderma Laboratories L.P. could learn from FDA before July whether it can introduce the first non-monograph OTC acne treatment ingredient, adapalene, in the first nonprescription product intended to do more than treat the condition at the surface of the skin.

During the public comment period of FDA's Nonprescription Drugs Advisory Committee meeting April 15 on the proposed first-in-class switch to be marketed as Differin Gel, a dermatology professor said allowing OTC

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• By Sarah Karlin-Smith

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• By Sue Sutter

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More from North America

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

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• By Michael McCaughan

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• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.