Prescription medicine
Aflibercept Brand names: Eylea, Zaltrap, Pavblu, Yesafili
Aflibercept (Eylea) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the aflibercept FDA label on DailyMed (effective April 6, 2026, Regeneron Pharmaceuticals, Inc); the BLA 125387 record on Drugs@FDA; every aflibercept label on DailyMed.
Highlights of the record
FDA label of April 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2
Forms and strengths
- 2 mg/.05ml
- 8 mg/.07ml
- 40 mg/ml
- 100 mg/4ml
- 200 mg/8ml
Injection (solution); solution (concentrate).
On the market
- Earliest approval on file
- November 18, 2011 Eylea, Regeneron Pharmaceuticals; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 5 of which 0 under generic applications, 5 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest May 15, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 32,367 through July 30, 2026
What is aflibercept used for?
From the label: indications and usageEYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)
Conditions named in the indications of aflibercept's FDA labels, with every medicine labeled for each:
From other aflibercept labelsColorectal cancer: ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing …
FDA pharmacologic class: Vascular Endothelial Growth Factor Inhibitor.
Source: FDA drug label (EYLEA HD), Regeneron Pharmaceuticals, Inc, effective April 6, 2026 (SPL set 86d8848b-111b-4da9-8957-7cccef1b8f66), via openFDA; the full label on DailyMed
Is there a generic for aflibercept (Eylea)?
No generic aflibercept is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has aflibercept been recalled?
The FDA's Enforcement Report lists 3 recalls naming aflibercept since 2012: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of aflibercept and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 15, 2024 | Class II | Regeneron Pharmaceuticals Inc | Lack of Assurance of Sterility: Complaints of syringe breakage |
| April 23, 2024 | Class II | Regeneron Pharmaceuticals Inc | Lack of Assurance of Sterility: Complaints of syringe breakage |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the aflibercept label say about other medicines?
The aflibercept label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name aflibercept. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorouracil | drug interactions | No clinically important pharmacokinetic interactions were found between ziv-aflibercept and irinotecan/SN-38 or fluorouracil [see Clinical Pharmacology (12.3) ]. |
| Ranibizumab | warnings and precautions | The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; … |
Other labels that name aflibercept
Source: FDA drug label (EYLEA HD), Regeneron Pharmaceuticals, Inc, effective April 6, 2026 (SPL set 86d8848b-111b-4da9-8957-7cccef1b8f66), via openFDA; the full label on DailyMed
What do FAERS reports show for aflibercept?
The FDA Adverse Event Reporting System holds 32,367 reports that list aflibercept among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,088 are coded as a death and 4,568 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to aflibercept
- medicines labeled for the same conditions
- Other vascular endothelial growth factor inhibitors
- the pharmacologic class, with prices and generics
- Aflibercept side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other