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General MedicationsINJECTIONStandard

EVKEEZA

EVINACUMAB-DGNB

Standard Dose
1200MG/8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview EVKEEZA is listed in Drugs@FDA under application 761181 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient EVINACUMAB-DGNB Form and strength SOLUTION; INJECTION - 1200MG/8ML Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-09-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview EVKEEZA is listed in Drugs@FDA under application 761181 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient EVINACUMAB-DGNB Form and strength SOLUTION; INJECTION - 1200MG/8ML Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-09-25 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.