osilodrostat

FDA Drug Profile — Isturisa

osilodrostat is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Isturisa. Available dosage form: tablet, coated.

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 )