Brimonidine Tartrate · Regulatory label update

FDA supplemental approval: Brimonidine Tartrate AND Timolol Maleate (Labeling)

U.S. Food and Drug Administration · June 30, 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 for a fixed-dose combination of brimonidine tartrate 0.2% and timolol maleate (equivalent to 0.5% base) as an ophthalmic solution, approved on 2026-06-30. The record documents a labeling update only and contains no clinical trial data, efficacy results, or safety findings.

What was studied

Regulatory label update. United States.

Key findings

Safety

This is a regulatory labeling supplement record; it does not contain clinical trial results, efficacy data, safety data, or comparative effectiveness information.

Who this may help

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

Plain-language summary

FDA supplemental approval for labeling of a fixed-dose combination ophthalmic agent; describes a regulatory action rather than clinical evidence of efficacy or safety.

Study design

As stated by the source record.

SettingUnited States

Reported figures

Quoted from the source exactly as published.

Brimonidine tartrate concentration0.2%

Timolol maleate concentrationequivalent to 0.5% base

Approval date2026-06-30

Caveats

This is a regulatory labeling supplement record; it does not contain clinical trial results, efficacy data, safety data, or comparative effectiveness information.
No study design, methodology, population, or outcomes are reported.
The record does not specify what labeling changes were made.

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 reported.

Directness

insufficient

Labeling supplement; does not report clinical trial outcomes or patient data.

Consistency

insufficient

No comparative or confirmatory data presented in this record.

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 ANDA217288. This is a regulatory action record, not a clinical study. Brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE. Active ingredient: BRIMONIDINE TARTRATE. Sponsor: AMNEAL. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-06-30. Products: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, SOLUTION/DROPS, OPHTHALMIC, BRIMONIDINE TARTRATE 0.2% + TIMOLOL MALEATE EQ 0.5% BASE.

Follow from this

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

AmnealBrimonidine Tartrate