Drug Approval Package: ERLEADA (apalutamide)

This review package includes Clinical Study Reports as part of a pilot project. The Clinical Study Report section provides information for pivotal clinical trials, not for all studies in the application. More information

Company:  Janssen Biotech
Application Number: 210951 Orig 1
Approval Date: 02/14/2018

Drugs@FDA information available about ERLEADA

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
• Officer/Employee List (PDF)
• Chemistry Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Sponsor Clinical Study Reports ARN-509-003 SPARTAN NCT # 01946204

• Clinical Study Report (body) (PDF)
• Protocol (PDF)
• Statistical Analysis Plan (PDF)

Date created: March 19, 2018, updated 3/29/2018, updated 7/6/2018

Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.

Note: Documents in PDF format require the Adobe Acrobat Reader®.