Remifentanil Hydrochloride · Regulatory label update

FDA supplemental approval: Remifentanil Hydrochloride (Labeling)

U.S. Food and Drug Administration · June 30, 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 supplemental FDA approval of labeling changes for remifentanil hydrochloride injectable formulations (1 mg, 2 mg, and 5 mg base per vial) by Fresenius Kabi USA, approved 30 June 2026. The record is a regulatory action and does not contain clinical trial results, efficacy data, or comparative evidence.

What was studied

Regulatory label update. Intervention: Remifentanil hydrochloride injectable (1 mg, 2 mg, 5 mg base per vial).

Key findings

Safety

This is a regulatory record of a labeling approval; it does not report clinical trial results, efficacy, or safety data.

Who this may help

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

Plain-language summary

FDA supplemental approval of labeling changes for remifentanil hydrochloride; regulatory action does not contain clinical trial data or efficacy evidence.

Study design

As stated by the source record.

InterventionRemifentanil hydrochloride injectable (1 mg, 2 mg, 5 mg base per vial)

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-30

Submission typeSupplemental labeling

Caveats

This is a regulatory record of a labeling approval; it does not report clinical trial results, efficacy, or safety data.
The specific content of labeling changes is not provided in this FDA action record.
No comparative data, study design, sample size, or outcome measures are reported.
This approval does not constitute evidence of clinical benefit or comparative effectiveness.

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 labeling record; not a clinical study.

Directness

insufficient

Record describes regulatory action, not clinical outcomes or trial data.

Consistency

insufficient

No comparative or confirmatory clinical data provided in this record.

Risk of bias

insufficient

Regulatory approval record does not assess or report bias in clinical evidence.

Sample adequacy

insufficient

No study population or sample size reported in labeling action record.

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 ANDA206223. This is a regulatory action record, not a clinical study. Brand name: REMIFENTANIL HYDROCHLORIDE. Active ingredient: REMIFENTANIL HYDROCHLORIDE. Sponsor: FRESENIUS KABI USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-30. Products: REMIFENTANIL HYDROCHLORIDE, INJECTABLE, INJECTION, REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL; REMIFENTANIL HYDROCHLORIDE, INJECTABLE, INJECTION, REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL; REMIFENTANIL HYDROCHLORIDE, INJECTABLE, INJECTION, REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL.

Follow from this

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

Remifentanil HydrochlorideFresenius Kabi U