Brimonidine Tartrate · Regulatory label update

FDA supplemental approval: Brimonidine Tartrate (Labeling)

U.S. Food and Drug Administration · May 20, 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 action for labeling of brimonidine tartrate 0.15% ophthalmic solution, approved by the regulator on 20 May 2026. The record confirms regulatory authorization for labeling changes but does not contain clinical trial results, efficacy data, or comparative safety information. Clinicians should consult the approved labeling and full prescribing information for indications, contraindications, and dosing.

What was studied

Regulatory label update.

Key findings

FDA supplemental approval issued 20 May 2026 for brimonidine tartrate ophthalmic solution labeling Product: brimonidine tartrate 0.15% solution/drops, ophthalmic formulation Sponsor: Apotex; ANDA application number ANDA078479

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative benefit 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 an established ophthalmic agent; documents regulatory action without reporting clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-20

Product strength0.15%

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative benefit information.
The nature of the labeling change (indication, warning, dosage, or other modification) is not specified in this record.
No sample size, endpoints, or statistical analyses are reported.
Clinical evidence supporting this product must be obtained from the approved labeling and FDA's full regulatory dossier.

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 endpoints or comparative outcomes.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Not applicable to regulatory labeling action.

Sample adequacy

insufficient

No clinical study population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA078479. This is a regulatory action record, not a clinical study. Brand name: BRIMONIDINE TARTRATE. Active ingredient: BRIMONIDINE TARTRATE. Sponsor: APOTEX. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-20. Products: BRIMONIDINE TARTRATE, SOLUTION/DROPS, OPHTHALMIC, BRIMONIDINE TARTRATE 0.15%.

Follow from this

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

Brimonidine TartrateApotex