Entecavir · Regulatory label update

FDA supplemental approval: Baraclude (Labeling)

U.S. Food and Drug Administration · August 18, 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 entecavir (Baraclude) approved on 18 August 2026. The record documents a regulatory action only and does not include clinical trial data, efficacy results, or comparative safety information.

What was studied

Regulatory label update.

Key findings

Safety

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

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling changes to entecavir; does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-18

Product formulations approvedEntecavir 0.5 mg tablet; Entecavir 1 mg tablet

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific labeling changes requested or approved are not detailed in this record.
No comparator, control arm, or comparative benefit information is provided.
No sample size, patient population characteristics, or study methodology is reported.

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 action record; no clinical study design present.

Directness

insufficient

Labeling supplement; does not report clinical endpoints or outcomes.

Consistency

insufficient

Single regulatory action; no comparative or replicate data reported.

Risk of bias

insufficient

Regulatory document; risk of bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample or trial population described.

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 NDA021797. This is a regulatory action record, not a clinical study. Brand name: BARACLUDE. Active ingredient: ENTECAVIR. Sponsor: BRISTOL MYERS SQUIBB. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-08-18. Products: BARACLUDE, TABLET, ORAL, ENTECAVIR 1MG; BARACLUDE, TABLET, ORAL, ENTECAVIR 0.5MG.

Follow from this

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

EntecavirBristol Myers Squibb