Apixaban · Regulatory label update

FDA supplemental approval: Eliquis (Labeling)

U.S. Food and Drug Administration · June 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 an FDA supplemental approval action for labeling changes to apixaban (Eliquis), approved 24 June 2026. The record does not contain clinical trial data, efficacy results, or safety analyses; it documents only the regulatory decision and formulation approvals.

What was studied

Regulatory label update.

Key findings

FDA approval of supplemental labeling application for apixaban (NDA220073) dated 2026-06-24 Four formulations approved: oral suspension 0.15 mg, tablets 5 mg and 0.5 mg, and sprinkle suspension 0.15 mg

Safety

This record does not contain clinical trial results, efficacy data, or safety analyses.

Who this may help

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

Plain-language summary

FDA supplemental approval action for labeling changes to apixaban (Eliquis); does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-24

NDA number220073

Caveats

This record does not contain clinical trial results, efficacy data, or safety analyses.
The specific labeling changes are not described in this regulatory record.
No comparative benefit or clinical outcome data are reported.
Approval date is future-dated (2026), which may indicate a data error or planned approval.

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 record; no clinical study design reported.

Directness

insufficient

Labeling action; clinical endpoints or trial data not provided.

Consistency

insufficient

No comparative data or consistency assessment included.

Risk of bias

insufficient

Not applicable to regulatory labeling submission.

Sample adequacy

insufficient

No sample size or study population reported.

Source abstract

Drugs@FDA record for application NDA220073. This is a regulatory action record, not a clinical study. Brand name: ELIQUIS. Active ingredient: APIXABAN. Sponsor: BRISTOL. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-24. Products: ELIQUIS, SUSPENSION, ORAL, APIXABAN 0.15MG; ELIQUIS, TABLET, ORAL, APIXABAN 5MG; ELIQUIS, TABLET, ORAL, APIXABAN 0.5MG; ELIQUIS SPRINKLE, FOR SUSPENSION, ORAL, APIXABAN 0.15MG.

Follow from this

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

BristolApixaban