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Data updated: May 26, 2026

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA (riboflavin 5'-phosphate sodium)

Other Approved 2016-04-15

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA is indicated for the treatment of Fever; Burns; Gastrointestinal Disorder; Alcoholism.

Source: FDA Label • GLAUKOS
2
Indications
--
Phase 3 Trials
2
Priority Reviews
10
Years on Market

Details

Status
Prescription
First Approved
2016-04-15
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: RIBOFLAVIN 5'-PHOSPHATE SODIUM

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2016 to 2025 · 1 indication expansions
Feb 2025 SUPPL
Label · Labeling
Jan 2019 SUPPL
Label · Labeling
Oct 2018 SUPPL
Mfg · Manufacturing (CMC)

What PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA Treats

4 indications

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA is approved for 4 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Fever
  • Burns
  • Gastrointestinal Disorder
  • Alcoholism
Source: FDA Label

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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Key Completed Trials

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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.

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA FDA Label Details

Indications & Usage

FDA Label (PDF)

PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA is indicated for the treatment of Fever; Burns; Gastrointestinal Disorder; Alcoholism.

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Data Sources

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