HEMGENIX

CSL Behring🇺🇸 United States

FDA Page

Effective Date: May 1, 2026
Approval ID: 35b2db65-4c6c-4173-ab56-b2bca69193bd
Products: 20 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 2022

Quick Stats

Total Products20

Labelers2

Label Sections56

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.