STN: 125426
Proper Name: Coagulation Factor IX (Recombinant)
Tradename: IXINITY
Manufacturer: Aptevo Bio Therapeutics LLC
Indication

• For routine prophylaxis to reduce the frequency of bleeding episodes in adults and children >/= 12 years of age with Hemophilia B
• Control and prevention of bleeding episodes and peri-operative management in patients with hemophilia B

Product Information

• Package Insert and Patient Information  - IXINITY

Supporting Documents

• March 3, 2021 Approval Letter - IXINITY
• February 17, 2021 Partial Rescission of Approval - IXINITY
• September 25, 2020 Approval Letter - IXINITY
• Clinical Review (STN: 125426/177) - IXINITY
• Statistical Review (STN: 125426/177) - IXINITY
• Approval History, Letters, Reviews, and Related Documents - IXINITY
• Supporting Documents older than three years - IXINITY