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FDA BLA · BLA761269

LEQEMBI

lecanemab

Sponsor: EISAI INC

APPLICATION
BLA761269
TYPE
BLA
ORIGINAL APPROVAL
2023-01-06
LATEST ACTION
2026-01-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LEQEMBIPrescription
LECANEMAB-IRMB 200MG/2ML · INJECTABLE · INJECTION
LEQEMBIPrescription
LECANEMAB-IRMB 500MG/5ML · INJECTABLE · INJECTION

Approval history

2026-01-16Labeling · Supplement 11 · standard — Label ↗AP
2025-12-15Labeling · Supplement 12 · standard — Label ↗AP
2025-12-15Labeling · Supplement 15 · standard — Label ↗AP
2025-08-21Labeling · Supplement 13 · standard — Letter ↗AP
2025-01-24Efficacy · Supplement 5 · standard — Label ↗AP
2024-11-14Labeling · Supplement 8 · standard — Label ↗AP
2023-07-06Efficacy · Supplement 1 · priority — Label ↗AP
2023-01-06Type 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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