For acute myeloid leukemia (AML). NDA 214759, held by Medexus. Treosulfan.
As of Nov 13, 2026, NDA 214759 (Grafapex), held by Medexus, was first approved by FDA on Jan 21, 2025, with 1 approved supplement and 1 published complete response letter.
GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML).. Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 21, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 30, 2021 | Grafapex (treosulfan)Clinical/Statistical, Clinical Pharmacology, Nonclinical | Approved |
| Grafapex1GM/VIAL · powder;intravenous | Treosulfan | RxReference drug |
| Grafapex5GM/VIAL · powder;intravenous | Treosulfan | RxReference drug |
| Feb 5, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Jan 21, 2025 | Original applicationNew molecular entity · Standard review | Approved |
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
