← FDA DRUG APPROVALS

FDA BLA · BLA761112

CABLIVI

caplacizumab

Sponsor: ABLYNX NV

APPLICATION
BLA761112
TYPE
BLA
ORIGINAL APPROVAL
2019-02-06
LATEST ACTION
2025-12-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CABLIVIPrescription
CAPLACIZUMAB-YHDP 11MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-12-23Efficacy · Supplement 18 · priority — Label ↗AP
2024-10-30Labeling · Supplement 13 · standard — Label ↗AP
2024-04-11Labeling · Supplement 11 · standard — Label ↗AP
2022-02-23Labeling · Supplement 9 · standard — Label ↗AP
2020-12-16Labeling · Supplement 7 · standard — Letter ↗AP
2019-02-06Type 1 - New Molecular Entity · Original · priority — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →