Zynteglo

Genetix Biotherapeutics Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 21, 2026
Approval ID: 86931613-c262-47f5-8202-bc31fa69ad3d
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

CELLULAR THERAPY

Status

Approved

Full Title

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

Quick Stats

Total Products1

Labelers2

Label Sections38

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.