FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

WESTLAKE VILLAGE, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE^® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. Once-daily ZORYVE cream 0.05% provides rapid and significant clearance of atopic dermatitis anywhere on the body and offers clinicians, parents, and caregivers of children ages 2 to 5 an alternative to steroids that can be used for any duration.

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