Sold as Defitelio. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Defibrotide Sodium (sold as Defitelio), first approved Mar 30, 2016, with 0 new uses approved and 0 published complete response letters.
| Defibrotide Dose-escalation for SOS Post-HSCTSinusoidal Obstruction Syndrome, Veno-occlusive Disease · New York Medical College | Phase 2 | Recruiting | Aug 14, 2023 |
| Defibrotide for the Treatment of Severe COVID-19Covid19 · Brigham and Women's Hospital | Phase 2 | Recruiting | Dec 3, 2020 |
| Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell DiseaseSickle Cell Disease · New York Medical College | Phase 2 | Recruiting | Feb 5, 2016 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 30, 2016 | DefitelioNDA 208114 · New molecular entity | Jazz Pharms Inc | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
