Food and Drug Administration

Pediatric Advisory Committee

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)