FDA Accepts Arcutis’ sNDA for Roflumilast Foam (Zoryve) for Scalp and Body PsO; PDUFA Date Set
The U.S. Food and Drug Administration (FDA) accepted Arcutis’ supplemental New Drug Application for roflumilast foam (Zoryve) for the scalp and body psoriasis in adults and adolescents ages 12 and up. The Prescription Drug User Fee Act (PDUFA) target action date is set for May 22, 2025. Roflumilast foam 0.3%, a once-daily, next generation phosphodiesterase-4 […]