TOFIDENCE

Organon LLC🇺🇸 United States

FDA Page

Effective Date: May 22, 2026
Approval ID: 1ab3207a-ebfe-4565-9ce5-3a1538815c83
Products: 3 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TOFIDENCE safely and effectively. See full prescribing information for TOFIDENCE. TOFIDENCE (tocilizumab-bavi) injection, for intravenous use Initial U.S. Approval: 2023 TOFIDENCE (tocilizumab-bavi) is biosimilar to ACTEMRA (tocilizumab).

Quick Stats

Total Products3

Labelers1

Label Sections44

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.