FLUORESCITE (fluorescein sodium)
FLUORESCITE Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
Details
- Status
- Prescription
- First Approved
- 2006-03-28
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
FLUORESCITE Approval History
What FLUORESCITE Treats
1 FDA approvalsOriginally approved for its first indication in 2006 .
- Other (1)
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06873815 | 25-002 | Ph 2 | recruiting | A Study of Fluorescein Sodium in People Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD) |
| NCT06054178 results posted | 71857 R25DC020174-03 | Ph 2 | completed | Identification of Nerves Using Fluorescein Sodium |
| NCT05664555 DOSE | B-2211-790-004 | Ph 4 | completed | Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study) |
| NCT04351373 results posted | 19-005178 | Ph 2 | completed | Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560 |
| NCT04017975 OPTIMA | P00031701 R56HL128813 | Ph 2 | active not recruiting | Optical Tissue Identification for Myocardial Architecture |
| NCT03189134 results posted | P00013570 R56HL128813 | Ph 1 | completed | Utilization of Confocal Microscopy During Cardiac Surgery |
| NCT04071080 | PH1.20180001 | Ph 1 | completed | The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples |
| NCT02028325 Fluorescein results posted | GCBS-0003 | Ph 4 | terminated | Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
FLUORESCITE FDA Label Details
Indications & Usage
FDA Label (PDF)FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.