APPLICATION
BLA761248
TYPE
BLA
ORIGINAL APPROVAL
2024-07-02
LATEST ACTION
2025-07-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KISUNLAPrescription
DONANEMAB-AZBT 350MG/20ML(17.5MG/ML) · INJECTABLE · INJECTION
Approval history
2024-07-02Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.