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Tofacitinib · Regulatory label update
U.S. Food and Drug Administration · June 30, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval record documenting a labeling change for Xeljanz (tofacitinib), approved on 30 June 2026. The record itself contains no clinical trial results, efficacy data, or safety findings; it is a regulatory administrative action only.
Regulatory label update.
This is an FDA supplemental approval record documenting a labeling change for Xeljanz (tofacitinib), approved on 30 June 2026. The record itself contains no clinical trial results, efficacy data, or safety findings; it is a regulatory administrative action only.
This is a regulatory action record, not a clinical study; no trial outcomes, efficacy data, or safety results are reported. No information on dosing, indications, contraindications, or adverse event updates is provided.
The source did not state who this applies to in practice.
FDA supplemental approval for labeling change to tofacitinib (Xeljanz); regulatory action only, no clinical trial data reported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application NDA203214. This is a regulatory action record, not a clinical study. Brand name: XELJANZ. Active ingredient: TOFACITINIB. Sponsor: PF PRISM CV. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-30. Products: XELJANZ, TABLET, ORAL, TOFACITINIB CITRATE EQ 10MG BASE; XELJANZ, TABLET, ORAL, TOFACITINIB CITRATE EQ 5MG BASE.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.