FDA Extends Review Period for Ruxolitinib Cream for Pediatric Atopic Dermatitis

FDA Extends Review of Opzelura for Pediatric Atopic Dermatitis

The FDA has extended the review period for the sNDA for ruxolitinib cream (Opzelura) for the treatment of children with atopic dermatitis.

FDA Extends Review Period for Ruxolitinib Cream for Pediatric Atopic Dermatitis

WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has announced a three-month extension for its review of the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®), submitted by Incyte for the treatment of children aged 2-11 with mild to moderate atopic dermatitis (AD). The new action date under the Prescription Drug User Fee Act (PDUFA) is now set for September 19, 2025. The review extension is to provide additio…

FDA Delays Opzelura Review: New Data Could Unlock Massive Pediatric Eczema Market

FDA requires additional CMC data for Opzelura's pediatric approval. Phase 3 trial showed significant efficacy in children 2-11 with atopic dermatitis. See full timeline.