TheraRadar

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Data updated: Mar 10, 2026

MAXITROL

DEXAMETHASONE Corticosteroid Hormone Receptor Agonists
Immunology Approved 1963-06-06
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
62
Years on Market

Details

Status
Prescription
First Approved
1963-06-06
Routes
OPHTHALMIC
Dosage Forms
SUSPENSION/DROPS, OINTMENT

Companies

HARROW EYE Novartis
Active Ingredient: DEXAMETHASONE , NEOMYCIN SULFATE , POLYMYXIN B SULFATE

MAXITROL Approval History

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What MAXITROL Treats

7 indications

MAXITROL is approved for 7 conditions since its original approval in 1963. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammatory Ocular Conditions
  • Bacterial Ocular Infection
  • Infective Conjunctivitis
  • Edema
  • Inflammation
  • Chronic Anterior Uveitis
  • Corneal Injury
Source: FDA Label

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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.

MAXITROL FDA Label Details

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Indications & Usage

FDA Label (PDF)

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. T...

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Data Sources

FDA Approval: NDA050023 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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