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Defitelio Approval History

  • FDA approved: Yes (First approved March 30th, 2016)
  • Brand name: Defitelio
  • Generic name: defibrotide
  • Company: Jazz Pharmaceuticals plc
  • Treatment for: Hepatic Veno-Occlusive Disease

Defitelio (defibrotide sodium) is a deoxyribonucleic acid derivative anticoagulant for the treatment of hepatic veno-occlusive disease with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.

Development History and FDA Approval Process for Defitelio

Mar 30, 2016Approval FDA Approves Defitelio (defibrotide sodium) for Hepatic Veno-Occlusive Disease Following Hematopoietic Stem-Cell Transplantation
Sep 30, 2015Jazz Pharmaceuticals Announces FDA Acceptance for Filing with Priority Review of NDA for Defibrotide
Dec 11, 2014Jazz Pharmaceuticals Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease

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