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FDA BLA · BLA761181

EVKEEZA

Sponsor: REGENERON PHARMACEUTICALS

APPLICATION
BLA761181
TYPE
BLA
ORIGINAL APPROVAL
2021-02-11
LATEST ACTION
2025-09-25
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EVKEEZAPrescription
EVINACUMAB-DGNB 345MG/2.3ML · SOLUTION · INJECTION
EVKEEZAPrescription
EVINACUMAB-DGNB 1200MG/8ML · SOLUTION · INJECTION

Approval history

2025-09-25Efficacy · Supplement 2 · priority — Letter ↗AP
2023-03-21Efficacy · Supplement 1 · priority — Label ↗AP
2021-02-11Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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