Brimonidine Tartrate · Regulatory approval

FDA approval: Brimonidine Tartrate AND Timolol Maleate

U.S. Food and Drug Administration · July 1, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a fixed-dose combination ophthalmic solution containing brimonidine tartrate 0.2% and timolol maleate 0.5% (equivalent base) as an original ANDA application on 1 July 2026. This is a regulatory action record and contains no clinical trial data, efficacy outcomes, or comparative safety information.

What was studied

Regulatory approval.

Key findings

Approval granted for brimonidine tartrate and timolol maleate fixed-dose combination, ophthalmic solution Product formulation: brimonidine tartrate 0.2% + timolol maleate equivalent 0.5% base

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No information provided on indication, dosing schedule, contraindications, or adverse event profile.

Who this may help

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

Plain-language summary

FDA approval of a fixed-dose combination ophthalmic drop; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative outcomes.

Reported figures

Quoted from the source exactly as published.

Brimonidine tartrate concentration0.2%

Timolol maleate concentration (equivalent base)0.5%

Approval date2026-07-01

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative effectiveness or bioequivalence study data are reported in this regulatory record.
Application type (ANDA) suggests this is a generic or follow-on product approval, but the source does not specify the reference listed drug or evidence supporting approval.
No information provided on indication, dosing schedule, contraindications, or adverse event profile.

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 clinical study design reported.

Directness

insufficient

Record does not report clinical outcomes or patient-level data.

Consistency

insufficient

No comparison with other studies or evidence base documented.

Risk of bias

insufficient

Regulatory approval record; methodological details not provided.

Sample adequacy

insufficient

No patient sample or study population described in this record.

Source abstract

Drugs@FDA record for application ANDA217934. This is a regulatory action record, not a clinical study. Brand name: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE. Active ingredient: BRIMONIDINE TARTRATE. Sponsor: SABA ILAC SANAYIVE. Submission type: ORIG (original application). Approval status date: 2026-07-01. 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.

Saba Ilac SanayiveBrimonidine Tartrate