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Data updated: Mar 10, 2026

DUREZOL

DIFLUPREDNATE
Ophthalmology Approved 2008-06-23
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
2
Priority Reviews
17
Years on Market

Details

Status
Prescription
First Approved
2008-06-23
Routes
OPHTHALMIC
Dosage Forms
EMULSION

Companies

Novartis
Active Ingredient: DIFLUPREDNATE

DUREZOL Approval History

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What DUREZOL Treats

3 indications

DUREZOL is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammation
  • Pain
  • Uveitis
Source: FDA Label

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Key Completed Trials

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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.

DUREZOL FDA Label Details

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Indications & Usage

FDA Label (PDF)

DUREZOL ® is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. • The treatment of endogenous anterior uveitis. 1.1 Ocular Surgery DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL is indicated for the treatment of endogenous anterior uveitis.

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Data Sources

FDA Approval: NDA022212 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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