TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PHOTOFRIN

PORFIMER SODIUM
Oncology Approved 1995-12-27
5
Indications
--
Phase 3 Trials
2
Priority Reviews
30
Years on Market

Details

Status
Prescription
First Approved
1995-12-27
Routes
Injection, INJECTION
Dosage Forms
Injectable, INJECTABLE

PHOTOFRIN Approval History

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What PHOTOFRIN Treats

3 indications

PHOTOFRIN is approved for 3 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Esophageal Cancer
  • Non-Small Cell Lung Cancer
  • Barrett's Esophagus
Source: FDA Label

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Trial Timeline

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.

PHOTOFRIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High...

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Data Sources

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