FDA Extends Topical Roflumilast’s Atopic Dermatitis Approval to Young Children

FDA Expands Roflumilast Access to Children as Young as Age 2 | Dermatology Times - Dermatology News and Clinical Insights

The approval represents the sixth FDA authorization for roflumilast since 2022.

FDA Approves Roflumilast Cream 0.05% for Atopic Dermatitis in Children 2 to 5

As the sixth approval for roflumilast in less than 4 years, the cream is expected to impact the 1.8 million children who have reported atopic dermatitis.

FDA Extends Roflumilast’s AD Approval to Young Children

The approval is for children ages 2-5 with mild-to-moderate atopic dermatitis. Medscape Medical News Source link : https://www.medscape.com/viewarticle/fda-extends-topical-roflumilasts-atopic-dermatitis-approval-2025a1000quo?src=rss Author : Publish date : 2025-10-06 20:11:00 Copyright for syndicated content belongs to the linked Source. The post FDA Extends Roflumilast’s AD Approval to Young Children first appeared on News Health.

FDA Expands Roflumilast Use for Atopic Dermatitis to Children Aged 2 to 5 Years

Roflumilast cream 0.05% gains FDA approval for young children, offering a safe, effective treatment for mild to moderate atopic dermatitis.

FDA Approves Roflumilast Cream for Pediatric Patients With Atopic Dermatitis | Pharmacy Times - Pharmacy Practice News and Expert Insights

The approval is supported by findings from the INTEGUMENT-PED trial and the INTEGUMENT-OLE long-term extension study.

FDA approves roflumilast cream 0.05% for atopic dermatitis for children aged 2 to 5 years

The once-daily, steroid-free cream can be used anywhere on the body for treatment, and for any duration, according to Arcutis.