Posted by Michael Wonder on 22 Jun 2025
Update on FDA review of ruxolitinib cream (Opzelura) for children ages 2-11 with atopic dermatitis
20 June 2025 - Incyte today announced that the US FDA has extended the review period for the supplemental new drug application for ruxolitinib cream (Opzelura), a topical Janus kinase inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis.
The PDUFA action date has been extended by three months to 19 September 2025.
