FDA Accepts Roflumilast Cream sNDA in Atopic Dermatitis for Ages 2-5 Years

FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children

This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.

FDA Accepts Supplemental New Drug Application for Arcutis’ Roflumilast in Children with AD

A PDUFA target action date has been set for October 13, 2025.

FDA Accepts Roflumilast Cream sNDA in Atopic Dermatitis for Ages 2-5 Years

On Feb. 26, 2025, Arcutis Biotherapeutics announced the FDA's acceptance of their sNDA for roflumilast cream 0.05% in AD for children aged 2 to 5 years.

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  - Arcutis Biotherapeutics

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 S…