ISTURISA (Recordati Rare Diseases Australia Pty Ltd)
Product name
ISTURISA
Date registered
Evaluation commenced
Decision date
Approval time
122 (255 working days)
Active ingredients
osilodrostat phosphate
Registration type
NCE/NBE
Indication
ISTURISA (film-coated tablet) is indicated for the treatment of endogenous Cushing's syndrome in adults.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.