An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Approved Blood Products

IXINITY

STN: 125426
Proper Name: Coagulation Factor IX (Recombinant)
Tradename: IXINITY
Manufacturer: Cangene Corporation
Indication:

Indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management.

Product Information

Package Insert - IXINITY

Supporting Documents

May 14, 2015 Approval Letter - IXINITY
The original posted document has been replaced with a revised approval letter correcting where labeling and packaging will be done.
Approval History, Letters, Reviews, and Related Documents - IXINITY
Supporting Documents older than three years - IXINITY