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Data updated: May 26, 2026

BETOPTIC S (betaxolol hydrochloride)

Ophthalmology Approved 1989-12-29

BETOPTIC S helps patients with chronic open-angle glaucoma or ocular hypertension by lowering high pressure inside the eye. This medication is used to manage elevated intraocular pressure, which is a significant risk factor for optic nerve damage and vision loss. By controlling these pressure levels, the drug helps protect the patient's visual field from further damage.

Source: FDA Label • Novartis

How BETOPTIC S Works

This medication works by inhibiting beta-1-adrenergic receptors to decrease the production of aqueous fluid within the eye. Reducing the amount of fluid produced leads to a lower level of intraocular pressure. While it targets the eye, it is designed to have minimal effects on a patient's heart or lung function.

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

Active Ingredient: BETAXOLOL HYDROCHLORIDE

BETOPTIC S Approval History

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Original
New Indication
New Form
Label Update
24 FDA actions from 1989 to 2021 · 1 indication expansions
Jun 2021 SUPPL
Label · Labeling
Feb 2017 SUPPL
Label · Labeling
Jun 2016 SUPPL
Mfg · Manufacturing (CMC)

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

BETOPTIC S Competitive Set

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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.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

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

Indications & Usage

FDA Label (PDF)

BETOPTIC S is indicated for the treatment of Chronic Open-Angle Glaucoma; Ocular Hypertension.

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Data Sources

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