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FDA BLA · BLA761142

UPLIZNA

inebilizumab

Sponsor: VIELA BIO

APPLICATION
BLA761142
TYPE
BLA
ORIGINAL APPROVAL
2020-06-11
LATEST ACTION
2025-12-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

UPLIZNAPrescription
INEBILIZUMAB-CDON 100MG/10ML · INJECTABLE · INJECTION

Approval history

2025-12-11Efficacy · Supplement 4 · standard — Letter ↗AP
2025-04-03Efficacy · Supplement 3 · priority — Label ↗AP
2020-06-11Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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