Food and Drug Administration

Immunosuppressive Drugs Subcommittee of the
Antiviral Drugs Advisory Committee

January 24, 2002

NDA 21-083 RapamuneŽ (sirolimus) Oral Solution - Cyclosporine Withdrawl Maintenance Regimen

Slides

Disclaimer

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.

RapamuneŽ, Introduction, Randy Brenner, MS, Worldwide Regulatory Affairs, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, Overview, John F Neylan, MD, Transplantation Immunology, Clinical Research & Development, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, CsA Elimination Studies, Design, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, CsA Elimination Studies, Efficacy, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, CsA Elimination Studies, Safety, Wyeth-Ayerst Research  ppt   htm

RapamuneŽ, Concentration-Controlled Trials and Therapeutic Drug Monitoring, James Zimmerman, PhD, Clinical Pharmacokinetics, Clinical Research & Development, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, Conclusions, John F Neylan, MD, Transplantation Immunology, Clinical Research & Development, Wyeth-Ayerst Research   ppt   htm

Backup Slides, Wyeth-Ayerst Research   ppt   htm

RapamuneŽ, Cyclosporine Withdrawal in Renal Transplantation, Rosemary Tiernan, MD, MPH, FDA   ppt   htm