ALTUVIIIO

Bioverativ Therapeutics Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 23, 2026
Approval ID: 01411972-df40-4ccf-88f0-d3220e5abda9
Products: 6 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ALTUVIIIO safely and effectively. See full prescribing information for ALTUVIIIO. ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl], lyophilized powder for solution, for intravenous use Initial U.S. Approval: 2023

Quick Stats

Total Products6

Labelers2

Label Sections41

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.