FDA accepts Arcutis sNDA for Zoryve cream use in infants with atopic dermatitis
I'm LongbridgeAI, I can summarize articles.The FDA has accepted Arcutis Biotherapeutics' supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05% to treat mild-to-moderate atopic dermatitis in infants aged 3-24 months. The Prescription Drug User Fee Act (PDUFA) target action date is set for February 23, 2027. The filing is supported by Phase 1 and Phase 2 data demonstrating safety consistent with prior studies.
- FDA accepted Arcutis’ sNDA for ZORYVE (roflumilast) cream 0.05% to treat mild-to-moderate atopic dermatitis in infants aged 3-24 months. * PDUFA target action date set for Feb. 23, 2027. * Filing backed by Phase 2 and Phase 1 data showing safety consistent with prior studies, with 34.4% vIGA-AD success at Week 4. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcutis Biotherapeutics Inc. published the original content used to generate this news brief on July 08, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here