XOSPATA (gilteritinib) tablets

XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

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XOSPATA (gilteritinib) tablets

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XOSPATA (gilteritinib) tablets

a certain type of acute myeloid leukemia (AML) that has worsened or returned after treatment with other chemotherapy medications

XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3
mutation as detected by an FDA-approved test.

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.[7] It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor.

In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients. Gilteritinib was approved for medical use in Australia in March 2020.

Drug (Brand / Generic): XOSPATA / gilteritinib
Current Indication: treat a certain type of acute myeloid leukemia (AML)
Approval Date:  2018

ACOVAÔ (argatroban) Injection is supplied in 2.5 mL solution in single-use vials at the concentration of 100 mg/mL. Each vial contains 250 mg of argatroban.

For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here

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