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U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis (AD) in the United States WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE
About this update from Arcutis Biotherapeutics, Inc.
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