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# FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs
- URL: https://www.fdaweb.com/fda-not-meeting-pdufa-dates-on-2-pfizer-ndas/
- Published: 2021-07-22T12:00:00.000Z
- Updated: 2026-09-14T17:07:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149764

FDA has notified Pfizer that it will not meet the already-extended PDUFA goal dates for the company’s NDA for abrocitinib to treat adults and adolescents with moderate to severe atopic dermatitis and the sNDA for Xeljanz/Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis. The agency cited its ongoing review of Pfizer’s ORAL Surveillance postmarketing safety study of Xeljanz in rheumatoid arthritis patients as a factor in the delay, Pfizer [said](https://www.businesswire.com/news/home/20210721005857/en/Pfizer-Provides-Update-on-U.S.-FDA-Review-of-Abrocitinib-and-XELJANZ%C2%AE-Filings?ref=fdaweb.com).

In April, the agency [said](https://www.fdaweb.com/jak-inhibitor-concerns-delay-lilly-pfizer-submissions/) that safety concerns with JAK inhibitors were causing review extensions for Lilly/Incyte and Pfizer submissions. The concerns arose from the FDA-required Xeljanz postmarketing safety study. FDA has warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice-daily dosage.