Colistimethate Sodium · Regulatory label update

FDA supplemental approval: Colistimethate (Labeling)

U.S. Food and Drug Administration · August 19, 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 for a labeling update to colistimethate sodium injection (150 mg per vial) issued 19 August 2026. The record documents a regulatory action only and does not contain clinical trial results, efficacy data, or outcome comparisons.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling update to colistimethate sodium injection; this is a regulatory action record without clinical trial data.

Reported figures

Quoted from the source exactly as published.

Product strength150 mg base per vial

Approval date2026-08-19

Caveats

This record does not contain clinical trial results, efficacy endpoints, or comparative safety data.
The specific labeling changes are not detailed in this regulatory record.
No information on indication, dosing recommendations, or contraindications is provided.
This is a supplemental approval; the nature and scope of the labeling change are not specified.

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 only; no efficacy or clinical outcome data provided.

Consistency

insufficient

No comparative or replicate data reported in this record.

Risk of bias

insufficient

Regulatory approval document; no trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size or patient population data in this labeling 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 ANDA065364. This is a regulatory action record, not a clinical study. Brand name: COLISTIMETHATE. Active ingredient: COLISTIMETHATE SODIUM. Sponsor: FRESENIUS KABI USA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-19. Products: COLISTIMETHATE SODIUM, INJECTABLE, INJECTION, COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL.

Follow from this

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

Fresenius Kabi UColistimethate Sodium