Label Changes for:

Casodex (bicalutamide) tablet

September 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

WARNINGS AND PRECAUTIONS

Hepatitis
  • Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Casodex.
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