SPEVIGO

LEO Pharma Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 16, 2026
Approval ID: 78a4f7eb-8d34-4467-8d40-74ed24323806
Products: 3 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2022

Quick Stats

Total Products3

Labelers1

Label Sections18

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.