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Ixinity FDA Approval History

Last updated by Judith Stewart, BPharm on March 26, 2024.

FDA Approved: Yes (First approved April 29, 2015)
Brand name: Ixinity
Generic name: coagulation factor IX (recombinant)
Dosage form: for Injection
Company: Emergent BioSolutions Inc.
Treatment for: Hemophilia B

Ixinity (coagulation factor IX (recombinant)) is a clotting factor IX therapy used to prevent bleeding in patients with hemophilia B.

Development timeline for Ixinity

DateArticle
Mar 26, 2024Approval FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Apr 30, 2015Approval Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B
Apr 18, 2012Inspiration Biopharmaceuticals Announces Filing of Biologics License Application (BLA) for IB1001, a Recombinant Factor IX Product for People with Hemophilia B

Further information

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