NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Mar 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
FLUORESCITE (fluorescein sodium) by Alcon is 12. Approved for hyperemia. First approved in 2006.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLUORESCITE (fluorescein sodium) is an intravenous diagnostic imaging agent that fluoresces under blue light (465-490 nm) to emit yellowish-green light (520-530 nm), enabling real-time visualization of retinal and choroidal vasculature during fundus photography. It is used to diagnose and evaluate hyperemia and other ocular vascular abnormalities by demarcating blood vessel patterns in the eye. The drug distributes rapidly to the eye within 7-14 seconds post-injection and undergoes hepatic conjugation followed by renal elimination.
LOE Approaching
Product is in LOE-approaching stage with moderate competitive pressure (30/100), suggesting defensive positioning and potential team contraction as generic entry nears.
Mechanism of Action
12.1 Mechanism of Action Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465-490 nm and fluoresces, i.e., emits light at wavelengths of 520-530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish-green. Following…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.