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FDA Accepts Arcutis’ Supplemental New Drug Application for ZORYVE Roflumilast Foam for Scalp and Body Psoriasis Treatment
Arcutis Biotherapeutics Announces FDA Acceptance of sNDA for ZORYVE Foam Introduction The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 for Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) foam 0.3%. This next-generation phosphodiesterase-4 (PDE4) inhibitor is aimed at…