FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5

Arcutis Biotherapeutics

6 October 2025 - Commercial product expected to be available by the end of October 2025.

Arcutis Biotherapeutics today announced that the US FDA has approved the supplemental new drug application for Zoryve (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.

Read Arcutis Biotherapeutics press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics