← FDA DRUG APPROVALS

FDA BLA · BLA125561

KANUMA

Sponsor: ALEXION PHARM

APPLICATION
BLA125561
TYPE
BLA
ORIGINAL APPROVAL
2015-12-08
LATEST ACTION
2024-07-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KANUMAPrescription
SEBELIPASE ALFA 20MG/10ML · INJECTABLE · INJECTION

Approval history

2024-07-10Labeling · Supplement 20 · standard — Letter ↗AP
2021-11-19Efficacy · Supplement 13 · standard — Label ↗AP
2015-12-08Type 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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