Posted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new drug application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
The Prescription Drug User Fee Act goal date has been extended three months to early Q3 2021.
The FDA has also extended the review period for the supplemental new drug applications for Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis by three months, with a goal date in early Q3 2021.
