General MedicationsINJECTIONStandard
REPATHA
EVOLOCUMAB
Standard Dose
140MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview REPATHA is listed in Drugs@FDA under application 125522 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient EVOLOCUMAB Form and strength INJECTABLE;INJECTION - 140MG/ML Sponsor AMGEN INC Submission history Latest submission status date: 2025-08-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview REPATHA is listed in Drugs@FDA under application 125522 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient EVOLOCUMAB Form and strength INJECTABLE;INJECTION - 140MG/ML Sponsor AMGEN INC Submission history Latest submission status date: 2025-08-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.