Label Changes for:

Zytiga (Abiraterone Acetate) Tablets

December 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 


December 2012



  • Zytiga can cause fetal harm when administered to a pregnant woman. Zytiga is not indicated for use in women…