Home » FDA Approves Amneal’s Generic Abiraterone Acetate 500mg Tablets
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.
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