Food and Drug Administration

Oncologic Drugs Advisory Committee

December 18, 2002

Briefing Information

Casodex® (bicalutamide)


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Casodex® (bicalutamide) Tablets, AstraZeneca Pharmaceuticals LP (PDF)

Overview, AstraZeneca Pharmaceuticals LP (HTM) (PDF) (Word)

Discussion Points, AstraZeneca Pharmaceuticals LP (HTM) (PDF) (Word)

Division Director's Review, FDA (HTM) (PDF) (Word)

Medical Officer's Primary Review of Efficacy and Safety, FDA (HTM) (PDF) (Word)

Background Information, FDA (HTM) (PDF) (Word)

Statistical Review and Evaluation, Clinical Studies of Casodex (bicalutamide) 150 mg, FDA (HTM) (PDF) (Word)