General MedicationsINJECTIONStandard
EYLEA HD
AFLIBERCEPT
Standard Dose
8MG(0.07ML;114.3MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview EYLEA HD is listed in Drugs@FDA under application 761355 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient AFLIBERCEPT Form and strength INJECTABLE;INJECTION - 8MG(0.07ML;114.3MG/ML) Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-11-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview EYLEA HD is listed in Drugs@FDA under application 761355 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient AFLIBERCEPT Form and strength INJECTABLE;INJECTION - 8MG(0.07ML;114.3MG/ML) Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-11-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.