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Data updated: Mar 10, 2026

BETOPTIC S

BETAXOLOL HYDROCHLORIDE
Cardiovascular Approved 1989-12-29
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
36
Years on Market

Details

Status
Prescription
First Approved
1989-12-29
Routes
OPHTHALMIC
Dosage Forms
SUSPENSION/DROPS

Companies

Novartis
Active Ingredient: BETAXOLOL HYDROCHLORIDE

BETOPTIC S Approval History

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What BETOPTIC S Treats

2 indications

BETOPTIC S is approved for 2 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Open-Angle Glaucoma
  • Ocular Hypertension
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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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.

BETOPTIC S FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

BETOPTIC S ® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension.

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Data Sources

FDA Approval: NDA019845 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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