Methotrexate · Regulatory label update

FDA supplemental approval: Methotrexate (Labeling)

U.S. Food and Drug Administration · May 27, 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 change to methotrexate sodium tablets (2.5 mg base) submitted by Eugia Pharma, approved on 27 May 2026. The record does not contain clinical trial data, efficacy outcomes, or safety results; it is an administrative action documenting regulatory approval of modified product labeling.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for methotrexate labeling update; regulatory action does not report clinical trial outcomes or efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-27

Dose strength2.5 mg base

Application numberANDA210454

Caveats

This record does not contain clinical trial results, efficacy data, or safety analysis.
Specific labeling changes are not detailed in this regulatory approval notice.
No comparator, control group, or outcome measures are reported.
No information on the clinical or scientific basis for the labeling update is provided.

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 action, not a clinical study.

Directness

insufficient

Labeling supplement; no clinical outcome data provided.

Consistency

insufficient

No comparative data or trial results reported.

Risk of bias

insufficient

Regulatory administrative record; bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size; regulatory submission only.

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 ANDA210454. This is a regulatory action record, not a clinical study. Brand name: METHOTREXATE. Active ingredient: METHOTREXATE. Sponsor: EUGIA PHARMA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-27. Products: METHOTREXATE SODIUM, TABLET, ORAL, METHOTREXATE SODIUM EQ 2.5MG BASE.

Follow from this

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

Eugia PharmaMethotrexate