NDA 208114, held by Jazz Pharms Inc. Defibrotide Sodium.
As of Nov 13, 2026, NDA 208114 (Defitelio), held by Jazz Pharms Inc, was first approved by FDA on Mar 30, 2016, with 0 approved supplements and 0 published complete response letters.
DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2016 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Defitelio200MG/2.5ML (80MG/ML) · solution;intravenous | Defibrotide Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
