← FDA DRUG APPROVALS

FDA BLA · BLA761244

SPEVIGO

spesolimab-sbzo

Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC

APPLICATION
BLA761244
TYPE
BLA
ORIGINAL APPROVAL
2022-09-01
LATEST ACTION
2025-10-21
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SPEVIGOPrescription
SPESOLIMAB-SBZO 900MG · INJECTABLE · INTRAVENOUS

Approval history

2025-10-21Labeling · Supplement 7 · standard — Label ↗AP
2025-05-28Labeling · Supplement 6 · standard — Letter ↗AP
2025-05-28Efficacy · Supplement 4 · standard — Letter ↗AP
2024-03-18Efficacy · Supplement 3 · standard — Label ↗AP
2022-09-01Type 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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