Quick answers
- What is Porfimer sodium used for?
- The FDA-approved label (Photofrin, Pinnacle Biologics, Inc., April 28, 2026) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Porfimer sodium have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Porfimer sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Porfimer sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 10, 2014 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Porfimer sodium?
- 1 company lists prescription products of Porfimer sodium in the FDA NDC Directory, including Pinnacle Biologics, Inc..
What Porfimer sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 …
— FDA label: Photofrin, Pinnacle Biologics, Inc., effective April 28, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Photofrin |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pinnacle Biologics, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020451 PHOTOFRIN | Pinnacle Biolgs | December 27, 1995 | 15, latest January 1, 2020 2020: Labeling · 2011: Labeling · 2011: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 10, 2014 · Class III · Terminated · D-1157-2014
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 — Pinnacle Biologics Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 242166, 687066 |
|---|---|
| SPL set ID of the quoted label | 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020451 |
| Active ingredients (FDA) | PORFIMER SODIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Photofrin, Pinnacle Biologics, Inc., effective April 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →