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# Pfizer Xeljanz sNDA Accepted for Ulcerative Colitis
- URL: https://www.fdaweb.com/pfizer-xeljanz-snda-accepted-for-ulcerative-colitis/
- Published: 2017-07-13T12:00:00.000Z
- Updated: 2026-09-14T22:34:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139128

FDA has accepted for review a Pfizer supplemental NDA for Xeljanz (tofacitinib citrate) for treating adult patients with moderately to severely active ulcerative colitis (UC). Tofacitinib citrate is a Janus kinase inhibitor currently approved for treating adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. The company expects a user fee review action date in 3/2018.  
  
The submission includes data from three Phase 3 studies (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) evaluating tofacitinib in patients with moderately to severely active UC, and OCTAVE Open, an open label long-term extension study.