osilodrostat

FDA Drug Profile — Isturisa

Drug Details

Generic Name
osilodrostat
Brand Names
Isturisa
Application Number
NDA212801
Sponsor
Recordati Rare Diseases, Inc.
NDC Codes
1
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
OSILODROSTAT PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE ISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. ISTURISA is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative ( 1 )