Xospata
Xospata ingredients
| Active ingredient | Strength |
|---|---|
| Gilteritinib Fumarate | 40 mg/1 |
What Xospata is used for
The FDA lists the approved uses on the official label (below). In the EU, gilteritinib is approved as Xospata for:
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Xospata
- Generic name
- Gilteritinib
- Made by
- Astellas Pharma US, Inc.
- Forms
- Tablet
- Given
- Oral
- FDA approval
- New drug application (NDA) NDA211349
- On the US market since
- 2018
Official information
- MedlinePlus drug information (search for Gilteritinib)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Xospata?
Xospata (Gilteritinib) is a cancer medicine made by Astellas Pharma US, Inc., approved by the US FDA.
What are the ingredients of Xospata?
Xospata contains Gilteritinib Fumarate (40 mg/1).
Is Xospata approved in Europe?
The same active substance is approved in the EU as Xospata.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA