RIXUBIS

Takeda Pharmaceuticals America, Inc.🇺🇸 United States

FDA Page

Effective Date: May 12, 2026
Approval ID: f5070a92-96b8-476a-a2dc-18b22d95e5e0
Products: 5 registered
Version: 14

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use RIXUBIS safely and effectively. See full prescribing information for RIXUBIS. RIXUBIS [Coagulation Factor IX (Recombinant)] For Intravenous Injection, Lyophilized Powder for Solution Initial U.S. Approval: 2013

Quick Stats

Total Products5

Labelers2

Label Sections45

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.