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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.