Quick answers
- What is Aflibercept used for?
- The FDA-approved label (Eylea, Regeneron Pharmaceuticals, Inc., July 7, 2026) says: “EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Retinopathy of Prematurity (ROP) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aflibercept have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Aflibercept?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aflibercept been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started May 15, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Aflibercept?
- 5 companies list prescription products of Aflibercept in the FDA NDC Directory, including Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC and Amgen, Inc.
What Aflibercept is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Retinopathy of Prematurity (ROP) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 …
— FDA label: Eylea, Regeneron Pharmaceuticals, Inc., effective July 7, 2026. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Regeneron Pharmaceuticals, Inc.3 products
- Sanofi-Aventis U.S. LLC2 products
- Amgen, Inc2 products
- Sandoz Inc1 product
- Biocon Biologics Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125387 EYLEA | Regeneron Pharmaceuticals | November 18, 2011 | 21, latest October 10, 2024 2024: Labeling · 2023: Labeling · 2023: Efficacy |
| BLA125418 ZALTRAP | Sanofi Aventis Us | August 3, 2012 | 8, latest December 13, 2023 2023: Labeling · 2020: Labeling · 2020: Labeling |
| BLA761274 YESAFILI | Biocon Biologics Inc | May 20, 2024 | 3, latest October 22, 2026 2026: Manufacturing (CMC) · 2026: Labeling · 2026: Manufacturing (CMC) |
| BLA761298 PAVBLU | Amgen Inc | August 23, 2024 | 1, latest October 22, 2026 2026: Bioequivalence |
| BLA761355 EYLEA HD | Regeneron Pharmaceuticals | August 18, 2023 | 4, latest April 2, 2026 2026: Efficacy · 2025: Efficacy · 2024: Labeling |
| BLA761382 ENZEEVU | Sandoz Inc | August 9, 2024 | 2, latest October 22, 2026 2026: Labeling · 2025: BIOSIMILAR |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 15, 2024 · Class II · Terminated · D-0531-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Roa — Regeneron Pharmaceuticals Inc
-
April 23, 2024 · Class II · Terminated · D-0479-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755- — Regeneron Pharmaceuticals Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1232154, 1232159, 1723187, 1723189, 1723193, 1723194, 2645305, 2645308, 2693564, 2693567 … (+4) |
|---|---|
| SPL set ID of the quoted label | f96cfd69-da34-41ee-90a9-610a4655cd1c |
| FDA labels (SPL) | 4 |
| FDA applications | BLA125387, BLA125418, BLA761274, BLA761298, BLA761355, BLA761382 |
| Active ingredients (FDA) | AFLIBERCEPT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Eylea, Regeneron Pharmaceuticals, Inc., effective July 7, 2026; 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 →