Posted by Michael Wonder on 15 Dec 2021
Incyte announces acceptance and priority review of sNDA for ruxolitinib cream (Opzelura) as a treatment for patients with vitiligo
14 December 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the supplemental new drug application for ruxolitinib cream 1.5% (Opzelura) a topical JAK inhibitor, as a potential treatment for adolescents and adults (age ≥12 years) with vitiligo.
The Prescription Drug User Fee Act target action date is 18 April 2022.
