TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BETAGAN

LEVOBUNOLOL HYDROCHLORIDE
Cardiovascular Approved 1985-12-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-19
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

AbbVie
Active Ingredient: LEVOBUNOLOL HYDROCHLORIDE

BETAGAN Approval History

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What BETAGAN Treats

2 indications

BETAGAN is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Glaucoma
  • Ocular Hypertension
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BETAGAN FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Levobunolol hydrochloride ophthalmic solution has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular hypertension.

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Data Sources

FDA Approval: NDA019219 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.