![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
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.
Upcoming Events
-
21Oct