THE ORAL SURVEILLANCE STUDY

Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings

Retrieved on: 
Wednesday, July 21, 2021

Pfizer is continuing to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to review the full results and analysis.

Key Points: 
  • Pfizer is continuing to work with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to review the full results and analysis.
  • Patients treated with XELJANZ* are at increased risk for developing serious infections that may lead to hospitalization or death.
  • * Unless otherwise stated, XELJANZ in the Important Safety Information refers to XELJANZ, XELJANZ XR, and XELJANZ Oral Solution.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.