Treats predominantly classic subfoveal choroidal neovascularization (CNV) due to…. NDA 21119, held by Bausch Lomb Ireland. Verteporfin.
As of Nov 14, 2026, NDA 21119 (Visudyne), held by Bausch Lomb Ireland, was first approved by FDA on Apr 12, 2000, with 16 approved supplements and 0 published complete response letters.
VISUDYNE (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.
| Jun 30, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Aug 22, 2001 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Apr 12, 2000 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Visudyne15MG/VIAL · injectable;injection | Verteporfin | RxReference drug |
| Feb 12, 2023 | Supplement 34Labeling · Standard review | Approved | |
| Jul 9, 2021 | Supplement 29Labeling · Standard review | Approved | |
| May 11, 2016 | Supplement 27Labeling · Standard review | Approved | |
| May 6, 2014 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Oct 8, 2013 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jun 28, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Jun 30, 2008 | Supplement 13Efficacy (new indication or use) | Approved | |
| Mar 28, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Mar 25, 2005 | Supplement 12Labeling · Standard review | Approved | |
| Feb 12, 2004 | Supplement 10Manufacturing · Priority review | Approved | |
| Feb 12, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Nov 25, 2002 | Supplement 5Labeling · Standard review | Approved | |
| May 29, 2002 | Supplement 4Manufacturing · Priority review | Approved | |
| Apr 30, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Feb 15, 2002 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 22, 2001 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Apr 12, 2000 | Original applicationNew molecular entity · Priority review | Approved |
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
