Rivaroxaban · Regulatory label update

FDA supplemental approval: Xarelto (Labeling)

U.S. Food and Drug Administration · March 24, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is a U.S. FDA supplemental approval record documenting a labeling change for rivaroxaban (Xarelto) oral suspension formulation (1 mg/mL), approved on 24 March 2026. The record does not contain clinical trial data, efficacy measures, or comparative outcomes; it is a regulatory administrative action only.

What was studied

Regulatory label update. Intervention: Rivaroxaban oral suspension, 1 mg/mL formulation. United States.

Key findings

Safety

This is a regulatory labeling action record and does not contain clinical trial results, efficacy data, or safety outcome measures.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for labeling change of an established anticoagulant; documents regulatory action but does not report clinical trial outcomes or comparative efficacy data.

Study design

As stated by the source record.

InterventionRivaroxaban oral suspension, 1 mg/mL formulation

SettingUnited States

Reported figures

Quoted from the source exactly as published.

Submission classLabeling

Approval status date2026-03-24

Formulation concentration1 MG/ML

Caveats

This is a regulatory labeling action record and does not contain clinical trial results, efficacy data, or safety outcome measures.
No comparator group, control arm, or comparative effectiveness data are reported.
The specific labeling changes are not detailed in this record.
No information is provided on the clinical basis or supporting evidence for the labeling modification.

Evidence assessment

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.

Study design

insufficient

Regulatory action record; no clinical study design reported.

Directness

insufficient

No clinical outcomes or efficacy data presented in this labeling record.

Consistency

insufficient

No comparative data or replication reported in this record.

Risk of bias

insufficient

Regulatory labeling record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No study population or sample size data in this regulatory submission.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application NDA215859. This is a regulatory action record, not a clinical study. Brand name: XARELTO. Active ingredient: RIVAROXABAN. Sponsor: JANSSEN PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-03-24. Products: XARELTO, FOR SUSPENSION, ORAL, RIVAROXABAN 1MG/ML.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Janssen PharmsRivaroxaban