Porfimer Sodium

Treats microinvasive endobronchial non-small-cell lung cancer (NSCLC). Sold as Photofrin. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 2 applications for Porfimer Sodium (sold as Photofrin), first approved Dec 27, 1995, with 3 new uses approved and 0 published complete response letters.

First approved: Dec 27, 1995
Applications: 2
New uses approved: 3
Complete response letters: 0
First approved in the EU: Mar 25, 2004

Orphan Designations (FDA)

5 designations, 2 approved for the designated use; see all orphan designations

Treatment of malignant mesotheliomaConcordia Laboratories, Inc., Sarl · designated Dec 2, 2011
Treatment of cholangiocarcinomaConcordia Laboratories, Inc., Sarl · designated Nov 18, 2004
For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients who are not considered to be candidates for…Axcan Scandipharm Inc. · designated Oct 19, 2001 · approved Aug 1, 2003
For the photodynamic therapy of patients with transitional cell carcinoma in situ of the urinary bladder.QLT Phototherapeutics, Inc. · designated Nov 15, 1989
For the photodynamic therapy of patients with primary or recurrent obstructing (either partially or completely)…QLT Phototherapeutics, Inc. · designated Jun 6, 1989 · approved Dec 27, 1995

Approvals in the EU (EMA)

First approved in the EU 99 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

PhotoBarr, new substancePinnacle Biologics B.V. · Mar 25, 2004 · withdrawn

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural MesotheliomaEpitheliod Malignant Pleural Mesothelioma · Abramson Cancer Center at Penn Medicine	Phase 2	Active, not recruiting	Jun 3, 2014

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 27, 1995	PhotofrinNDA 20451 · New molecular entity	Pinnacle Biolgs	15	Marketed
Aug 1, 2003	PhotofrinNDA 21525 · TYPE 6	Axcan Scandipharm	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA