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


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