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