XOSPATA (gilteritinib) tablets, for oral use. Initial U.S. Approval: 2018

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XOSPATA (gilteritinib) tablets, for oral use. Initial U.S. Approval: 2018

INDICATIONS AND USAGE
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.
DOSAGE FORMS & STRENGTHS
120 mg orally once daily.
Manufactured By: Astellas Pharma US, Inc
Prescribing Information URL: Click Here

Access to XOSPATA ® (gilteritinib) tablets: Anticancer drugs available upon request. To get best price please share your mobile number to receive quotes from Medvitaz Pharma Solutions.

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug. It acts as an inhibitor of AXL receptor tyrosine kinase, hence it is a tyrosine kinase inhibitor.
It was developed by Astellas Pharma.
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.

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