Capecitabine · Regulatory label update

FDA supplemental approval: Capecitabine (Labeling)

U.S. Food and Drug Administration · May 7, 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. FDA supplemental approval record documenting a labeling change for capecitabine (150 mg and 500 mg tablets, oral) manufactured by Amneal Pharmaceuticals, approved 7 May 2026. The record itself contains no clinical trial results, efficacy data, comparative evidence, or safety findings; it is solely a regulatory action notification.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval action for capecitabine labeling; documents a regulatory decision but contains no clinical trial data or efficacy evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-07

Product strengths approved150 mg and 500 mg tablets, oral

Submission typeSupplemental labeling

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety evidence.
The specific labeling changes are not detailed in this record.
No comparative data or outcomes are reported.
The record does not indicate the therapeutic indication, dose recommendations, or clinical trial supporting data for capecitabine.

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

No clinical outcomes or comparisons reported in this record.

Consistency

insufficient

Labeling submission does not include comparative or replication data.

Risk of bias

insufficient

Not applicable to a regulatory labeling action.

Sample adequacy

insufficient

No study population or sample size 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 ANDA204741. This is a regulatory action record, not a clinical study. Brand name: CAPECITABINE. Active ingredient: CAPECITABINE. Sponsor: AMNEAL PHARMS. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-07. Products: CAPECITABINE, TABLET, ORAL, CAPECITABINE 150MG; CAPECITABINE, TABLET, ORAL, CAPECITABINE 500MG.

Follow from this

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

Amneal PharmsCapecitabine