TECELRA

USWM, LLC🇺🇸 United States

FDA Page

Effective Date: Jul 15, 2026
Approval ID: ab24631f-3364-46e1-8074-7244863bcbab
Products: 1 registered
Version: 15

Regulatory Information

Labeling Type

CELLULAR THERAPY

Status

Approved

Full Title

These highlights do not include all the information needed to use TECELRA safely and effectively. See full prescribing information for TECELRA. TECELRA (afamitresgene autoleucel) suspension, for intravenous infusion Initial U.S. Approval: 2024

Quick Stats

Total Products1

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.