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FDA BLA · BLA761333

BKEMV

eculizumab-aeeb

Sponsor: AMGEN INC

APPLICATION
BLA761333
TYPE
BLA
ORIGINAL APPROVAL
2024-05-28
LATEST ACTION
2026-06-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BKEMVPrescription
ECULIZUMAB-AEEB 300MG/30ML(10MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-29Bioequivalence · Supplement 8 — Letter ↗AP
2026-03-26REMS · Supplement 7 — Letter ↗AP
2025-11-24Labeling · Supplement 5 · standard — Letter ↗AP
2025-09-17REMS · Supplement 6 — Letter ↗AP
2025-04-18REMS · Supplement 4 — Letter ↗AP
2025-01-30REMS · Supplement 3 — Letter ↗AP
2024-10-23BIOSIMILAR · Supplement 1 · standard — Letter ↗AP
2024-05-28Type 2 - New Active Ingredient · Original · standard — Label ↗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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