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Data updated: May 26, 2026

BETAGAN (levobunolol hydrochloride)

Ophthalmology Approved 1985-12-19

BETAGAN is indicated for the treatment of Glaucoma; Ocular Hypertension.

Source: FDA Label • AbbVie
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
40
Years on Market

Details

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

Companies

AbbVie
Active Ingredient: LEVOBUNOLOL HYDROCHLORIDE

BETAGAN Approval History

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Original
New Indication
New Form
Label Update
40 FDA actions from 1985 to 2017
Dec 2017 SUPPL
Label · Labeling
FDA Letter Label
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)
Mar 2003 SUPPL
Label · Labeling

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

BETAGAN Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

ZOLYMBUS
THEA PHARMA
2025 2 indic.
LATANOPROSTENE BUNOD
GLAND
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BETAGAN

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALPHAGAN P
BRIMONIDINE TARTRATE
2 shared
AbbVie
Shared indications:
GlaucomaOcular Hypertension
BETOPTIC
BETAXOLOL HYDROCHLORIDE
2 shared
Novartis
Shared indications:
GlaucomaOcular Hypertension
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
BRIMONIDINE TARTRATE
2 shared
CAPLIN
Shared indications:
GlaucomaOcular Hypertension
View all 20 similar drugs Pro
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Active Pipeline

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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

Indications & Usage

FDA Label (PDF)

BETAGAN is indicated for the treatment of Glaucoma; Ocular Hypertension.

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Data Sources

FDA Approval: NDA019814 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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