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XOSPATA (Astellas Pharma Australia Pty Ltd)
Product name
XOSPATA
Date registered
Evaluation commenced
Decision date
Approval time
151 working days (255)
Active ingredients
gilteritinib fumarate
Registration type
NCE/NBE
Indication
XOSPATA (film coated tablets) is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.