Quick answers
- What is Verteporfin for injection used for?
- The FDA-approved label (Visudyne, Bausch Health US LLC, August 27, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Verteporfin for injection have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Verteporfin for injection?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Verteporfin for injection been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Verteporfin for injection?
- 2 companies list prescription products of Verteporfin for injection in the FDA NDC Directory, including Bausch Health US, LLC and Bausch & Lomb Incorporated.
What Verteporfin for injection is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Visudyne, Bausch Health US LLC, effective August 27, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Visudyne |
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.
- Bausch Health US, LLC1 product
- Bausch & Lomb Incorporated1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021119 VISUDYNE | Bausch Lomb Ireland | April 12, 2000 | 16, latest February 12, 2023 2023: Labeling · 2021: Labeling · 2016: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 313595, 351914 |
|---|---|
| SPL set ID of the quoted label | 952f4c80-50b1-4308-9ee6-311ffefb13df |
| FDA labels (SPL) | 2 |
| FDA applications | NDA021119 |
| Active ingredients (FDA) | VERTEPORFIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Visudyne, Bausch Health US LLC, effective August 27, 2025; 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 →