Food and Drug Administration
February 15, 2005
Briefing Information
FDA
Briefing Memorandum (PDF)
Division of Pediatirc Drug Development Recommendation (PDF)
Tacrolimus Topical (Protopic®, NDA 50-777) (PDF)
Pimecrolimus (Elidel®, NDA 21-302) (PDF)
Elidel® and Protopic® Drug Review (PDF)
Pimecrolimus and Tacrolimus Update on Malignancy Related Events in All Age Groups (PDF)
Pharmacokinetics/Toxicokinetics Review (PDF)
Elidel® (pimecrolimus) Cream Label (PDF)
Protopic® (tacrolimus) Ointment Label (PDF)
Fujisawa Healthcare, Inc.
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.
Cover Letter (PDF)
Protopic® Background Package (HTM) (PDF) (Word)
Novartis Pharmaceutical Corp.
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.
Lymphoma Case Review, Dr. Jonathan Friedberg (HTM) (PDF) (Word)
Lymphoma Case Review, Dr. Kamel, MD (HTM) (PDF) (Word)
Lymphoma Case Review, Dr. Lazarus, MD, FACP (HTM) (PDF) (Word)
Elidel (pimecrolimus) Cream 1% Briefing Document (HTM) (PDF) (Word)
Safety Summary Children Population (PDF)
Safety Summary Adult Population (PDF)
Safety Summary Infant Population (PDF)