LENMELDY

Orchard Therapeutics (Europe) Ltd🇺🇸 United States

FDA Page

Effective Date: Aug 12, 2025
Approval ID: b3e307a7-561b-43b6-a784-9cb1dcfc5196
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 LENMELDY safely and effectively. See full prescribing information for LENMELDY. LENMELDY (atidarsagene autotemcel) suspension for intravenous infusion Initial U.S. Approval

Quick Stats

Total Products1

Labelers1

Label Sections32

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.