Today the U.S. FDA approved Zoryve (roflumilast) cream 0.05% for mild to moderate atopic dermatitis (AD) treatment in children ages 2 to 5, offering a safe and effective steroid-free option for young patients.

The once-daily Zoryve cream 0.05% helps treat AD by reducing the inflammation that causes symptoms. It targets a protein called phosphodiesterase 4 (PDE4), which plays a role in skin inflammation. By targeting this protein, the cream can lower the body’s inflammatory response and help calm irritated skin, improving symptoms quickly anywhere on the body.

Today’s approval comes after the FDA accepted Arcutis’ supplemental New Drug Application (sNDA) for the cream and an initial Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025.

Zoryve targets the most com

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