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Jivi FDA Approval History

Last updated by Judith Stewart, BPharm on May 26, 2025.

FDA Approved: Yes (First approved August 30, 2018)
Brand name: Jivi
Generic name: antihemophilic factor [recombinant] PEGylated-aucl
Dosage form: Injection
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A

Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, factor VIII concentrate used to treat and control bleeding in patients with hemophilia A.

Development timeline for Jivi

DateArticle
May 19, 2025Approval U.S. FDA Grants Approval for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl) in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A
Aug 30, 2018Approval Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A

Further information

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