Food and Drug Administration
Immunosuppressants Subcommittee
of the
Antiviral Drugs Advisory Committee
January 24, 2002
Briefing Information
NDA 21-083/SE1-006, 21-110/SE-004 Rapamune® (sirolimus) oral solution and tablets
Sponsor Briefing Information
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.
Summary for Presentation, Wyeth-Ayerst Research pdf
Food and Drug Administration Information
Clinical/Statistical Background Information for 27 July l999 Advisory Committee Meeting ppt htm doc
Rapamune® (sirolimus) Oral Solution and Tablets Label ppt htm doc
Clinical/Statistical Background Information for January 24, 2002 Advisory Committee Meeting ppt htm doc