Abiraterone Acetate is an antiandrogen medication, which is used in the treatment of castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer), prostate cancer that is not responding to androgen deprivation or treatment with antiandrogens. It is specifically indicated for use in conjunction with castration and prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and in the treatment of metastatic high-risk castration-sensitive prostate cancer (mCSPC). It is taken by mouth once per day on an empty stomach.
US DMF was submitted to FDA on 28/11/2012 and the following number was assigned n. 26725.
Drug product containing Sterling’s Abiraterone Acetate is commercialized in the USA.