Lutathera

Advanced Accelerator Applications USA, Inc🇺🇸 United States

FDA Page

Effective Date: Mar 7, 2023
Approval ID: 72d1a024-00b7-418a-b36e-b2cb48f2ab55
Products: 1 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use LUTATHERA safely and effectively. See full prescribing information for LUTATHERA. LUTATHERA (lutetium Lu 177 dotatate) injection, for intravenous use Initial U.S. Approval: 2018

Quick Stats

Total Products1

Labelers2

Label Sections24

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.