abiraterone acetate

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

abiraterone acetate is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand names including ABIRATERONE ACETATE, abiraterone acetate, YONSA. Available dosage forms: tablet, tablet, film coated.

Drug Details

Generic Name
abiraterone acetate
Brand Names
ABIRATERONE ACETATE, abiraterone acetate, YONSA, Abiraterone Acetate, Zytiga
Application Number
NDA210308
Sponsor
Golden State Medical Supply, 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 )