Methotrexate · Regulatory label update

FDA supplemental approval: Trexall (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 a U.S. Food and Drug Administration supplemental approval record documenting a labeling change for TREXALL (methotrexate) tablets in four strengths (5 mg, 7.5 mg, 10 mg, and 15 mg base equivalent) approved on 27 May 2026. The record confirms regulatory action but does not contain clinical trial data, efficacy results, or safety outcomes.

What was studied

Regulatory label update. United States (FDA).

Key findings

Safety

This is a regulatory record and does not contain clinical trial results, efficacy data, or safety outcomes. No comparative effectiveness, adverse event rates, or dosing recommendations are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling change to methotrexate tablet formulations; documents regulatory action only, not clinical trial data.

Study design

As stated by the source record.

SettingUnited States (FDA)

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-27

Formulations approved5 mg, 7.5 mg, 10 mg, 15 mg methotrexate sodium tablet (oral)

Caveats

This is a regulatory record and does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes made are not detailed in this record.
No comparative effectiveness, adverse event rates, or dosing recommendations are reported.
The record does not indicate the clinical rationale or evidence supporting the labeling supplement.

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 trial design reported.

Directness

insufficient

Labeling change; clinical outcomes not addressed in this record.

Consistency

insufficient

No comparative data or efficacy assessment provided.

Risk of bias

insufficient

Not applicable to regulatory labeling submission.

Sample adequacy

insufficient

No study population; regulatory action 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 ANDA040385. This is a regulatory action record, not a clinical study. Brand name: TREXALL. Active ingredient: METHOTREXATE. Sponsor: BARR. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-27. Products: TREXALL, TABLET, ORAL, METHOTREXATE SODIUM EQ 7.5MG BASE; TREXALL, TABLET, ORAL, METHOTREXATE SODIUM EQ 10MG BASE; TREXALL, TABLET, ORAL, METHOTREXATE SODIUM EQ 5MG BASE; TREXALL, TABLET, ORAL, METHOTREXATE SODIUM EQ 15MG BASE.

Follow from this

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

BarrMethotrexate