Photofrin

NDA 21525, held by Axcan Scandipharm. Porfimer Sodium.

As of Nov 14, 2026, NDA 21525 (Photofrin), held by Axcan Scandipharm, was first approved by FDA on Aug 1, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 1, 2003
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 1, 2003	Original applicationTYPE 6 · Priority review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Photofrin75MG/VIAL · injectable; injection	Porfimer Sodium	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Jan 1, 2020	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 1, 2003	Original applicationTYPE 6 · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 21525
Drugs@FDA: Overview at FDA
Company: Axcan Scandipharm

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters