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 action for a labeling change to entecavir (Baraclude) oral solution 0.05 mg/mL, approved on 18 August 2026. The record does not contain clinical trial results, efficacy data, or comparative safety information; it documents a regulatory decision only.

What was studied

Regulatory label update.

Key findings

FDA approved supplemental application NDA021798 for Baraclude (entecavir) oral solution labeling on 2026-08-18

Safety

Record does not contain clinical trial results, efficacy data, or safety comparators.

Who this may help

This record does not report clinical trial outcomes or comparative efficacy. Clinicians should consult the updated product labeling for any changes to dosing, indications, contraindications, or safety information.

Plain-language summary

FDA supplemental approval for labeling change to entecavir; describes regulatory action only, not clinical trial outcomes or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Formulation strength0.05 mg/mL

Approval date2026-08-18

Clinical bottom line

Caveats

Record does not contain clinical trial results, efficacy data, or safety comparators.
Specific nature and content of labeling change are not detailed in this record.
No information on population, study design, or outcomes 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

Regulatory record; no study design reported.

Directness

insufficient

Labeling action only; clinical outcomes not described.

Consistency

insufficient

No comparative data or prior results cited in record.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No study population or sample size reported.

Source abstract

Drugs@FDA record for application NDA021798. 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, SOLUTION, ORAL, ENTECAVIR 0.05MG/ML.

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