en.wikipedia.org/wiki/Photodynamic_therapy
2 corrections found
Benzoporphyrin derivative monoacid ring A (BPD-MA), marketed as Visudyne (Verteporfin, for injection), has been approved by health authorities in multiple jurisdictions, including US FDA, for the treatment of wet AMD beginning in 1999.
The U.S. FDA date is off by a year. The official U.S. label for Visudyne lists its initial U.S. approval as 2000, not 1999.
Full reasoning
This sentence is too early for the U.S. approval timeline. The official DailyMed label for VISUDYNE (verteporfin for injection) states "Initial U.S. Approval: 2000." So while some non-U.S. regulatory activity may have happened around 1999, it is inaccurate to say approval "including US FDA" began in 1999.
A more accurate wording would separate jurisdictions, e.g. noting that U.S. FDA approval was in 2000.
1 source
- DailyMed - VISUDYNE- verteporfin for injection injection, powder, lyophilized, for solution
VISUDYNE (verteporfin for injection), for intravenous use Initial U.S. Approval: 2000
In 1994, the FDA approved PDT with the photosensitizer porfimer sodium for palliative treatment of advanced esophageal cancer
The year is wrong. FDA records show porfimer sodium (Photofrin) was approved in the U.S. in 1995, not 1994, for palliative treatment of obstructing esophageal cancer.
Full reasoning
FDA sources contradict the 1994 date. The current official DailyMed label for PHOTOFRIN (porfimer sodium) lists "Initial U.S. Approval: 1995." The FDA's Orphan Drug Designations and Approvals database is even more specific: it gives December 27, 1995 as the marketing approval date for Photofrin for the palliation of patients with completely or partially obstructing esophageal cancer.
So the problem is not the indication itself, but the approval year: the FDA approval happened in 1995, not 1994.
2 sources
- DailyMed - PHOTOFRIN- porfimer sodium injection, powder, for solution
PHOTOFRIN (porfimer sodium) for injection, for intravenous use Initial U.S. Approval: 1995
- FDA Orphan Drug Designations and Approvals - Photofrin
Marketing Approval Date: 12/27/1995 ... Approved Labeled Indication: Photodynamic therapy with PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer