Tranexamic Acid · Regulatory label update

FDA supplemental approval: Tranexamic Acid (Labeling)

U.S. Food and Drug Administration · April 28, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA approved a supplemental application for labeling changes to tranexamic acid injectable 100 mg/mL (ANDA 205035) on 28 April 2026. This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

Safety

This regulatory record does not contain clinical trial results, efficacy data, safety findings, or the specific labeling changes approved.

Who this may help

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

Plain-language summary

This is an FDA supplemental approval action for labeling of an existing drug; it does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-04-28

Application numberANDA205035

Drug strength100 mg/mL

Caveats

This regulatory record does not contain clinical trial results, efficacy data, safety findings, or the specific labeling changes approved.
No comparative benefit, mechanism of action, or indication data is reported in this record.
The sponsor, indication, and clinical context for 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

This is a regulatory record, not a clinical study.

Directness

insufficient

Regulatory action does not report clinical trial data or outcomes.

Consistency

insufficient

No comparative data or prior studies cited in this record.

Risk of bias

insufficient

Regulatory record does not describe study methods or bias assessment.

Sample adequacy

insufficient

This is not a clinical trial; no sample size is reported.

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 ANDA205035. This is a regulatory action record, not a clinical study. Brand name: TRANEXAMIC ACID. Active ingredient: TRANEXAMIC ACID. Sponsor: EUGIA PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-28. Products: TRANEXAMIC ACID, INJECTABLE, INJECTION, TRANEXAMIC ACID 100MG/ML.

Follow from this

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

Eugia PharmaTranexamic Acid