FDA Approves Amneal’s Generic Abiraterone Acetate 500mg Tablets

The FDA has approved Amneal Pharmaceuticals’ application for a 500mg abiraterone acetate tablet, a generic version of Janssen Pharmaceuticals’ Zytiga for the treatment of metastatic prostate cancer.

The agency noted that the drug carries numerous risks, such as hepatotoxicity, greater instances of fractures, embryo-fetal toxicity, hypoglycemia and a risk of death if used with radium Ra 223 dichloride.

Amneal said it will immediately launch the 500-mg dose in addition to the previously approved 250-mg dosage.