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GlobeNewswire·

FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label