CARVYKTI

Janssen Biotech, Inc.🇺🇸 United States

FDA Page

Effective Date: Oct 16, 2025
Approval ID: 7d040b91-3fb8-41db-ba7f-60a36f06e2c2
Products: 1 registered
Version: 19

Regulatory Information

Labeling Type

CELLULAR THERAPY

Status

Approved

Full Title

These highlights do not include all the information needed to use CARVYKTI safely and effectively. See full prescribing information for CARVYKTI. CARVYKTI (ciltacabtagene autoleucel) suspension for intravenous infusion Initial U.S. Approval: 2022

Quick Stats

Total Products1

Labelers1

Label Sections20

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.