TheraRadar
Data updated: May 26, 2026

FLURBIPROFEN SODIUM

Ophthalmology Approved 1995-01-04

FLURBIPROFEN SODIUM is indicated for the treatment of Miosis.

Source: FDA Label • BAUSCH AND LOMB
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1995-01-04
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

BAUSCH AND LOMB
Active Ingredient: FLURBIPROFEN SODIUM

FLURBIPROFEN SODIUM Approval History

1996
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Original
New Indication
New Form
Label Update
15 FDA actions from 1995 to 2013
Jan 2013 SUPPL
Label · Labeling
Dec 2002 SUPPL
Label · Labeling
Nov 2001 SUPPL
Mfg · Manufacturing (CMC)

What FLURBIPROFEN SODIUM Treats

1 indications

FLURBIPROFEN SODIUM is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Miosis
Source: FDA Label

FLURBIPROFEN SODIUM Competitive Set

Pro

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

Indication competitors

2

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

OMIDRIA
RAYNER SURGICAL
2014 2 indic.
MIOSTAT
Novartis
1972 2 indic.

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 FLURBIPROFEN SODIUM

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

MIOSTAT
CARBACHOL
1 shared
Novartis
Shared indications:
Miosis
OMIDRIA
KETOROLAC TROMETHAMINE
1 shared
RAYNER SURGICAL
Shared indications:
Miosis
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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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.

FLURBIPROFEN SODIUM FDA Label Details

Indications & Usage

FLURBIPROFEN SODIUM is indicated for the treatment of Miosis.

Looking for the branded version?

OCUFEN

Full clinical data, patents, trials, and competitive landscape for flurbiprofen sodium.

See OCUFEN

Data Sources

FDA Approval: ANDA074447 → Label: DailyMed → Trials: ClinicalTrials.gov →

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