abiraterone acetate

FDA Drug Profile — Zytiga, Abiraterone Acetate, YONSA, abiraterone acetate

Drug Details

Generic Name
abiraterone acetate
Brand Names
Zytiga, Abiraterone Acetate, YONSA, abiraterone acetate
Application Number
NDA202379
Sponsor
Janssen Biotech, Inc.
NDC Codes
13
Dosage Forms
TABLET, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ABIRATERONE ACETATE

Indications and Usage

1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with • Metastatic castration-resistant prostate cancer (CRPC) • Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with • metastatic castration-resistant prostate cancer (CRPC). ( 1 ) • metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )