Food and Drug Administration

Pediatric Advisory Committee

November 18, 2005

Briefing Information

Briefing Memorandum - Overview (PDF)

Review of Anagrelide AE (PDF)

Anagrelide BPCA Final - Cleared October 3, 2005 (PDF)

Anagrelide Clinical Review (PDF)

Anagrelide Clinical Pharmacology Summary (PDF)

Review of Carboplatin AE (PDF)

Anagrelide Label (PDF)

Carboplatin Use Final - Cleared (PDF)

Carboplatin Clinical Review (PDF)

Carboplatin Clinical Pharmacology Summary (PDF)

Carboplatin Label (PDF)

Diflucan AE (PDF)

Difllucan Drug Use Review - Final (PDF)

Diflucan BPCA Executive Summary (PDF)

Diflucan Clinical Pharmacology Summary (PDF)

Diflucan Label (PDF)

Irinotecan AE (PDF)

Irinotecan BPCA - Cleared (PDF)

Irinotecan Medical Review (PDF)

Irinotecan Clinical Pharmacology Summary (PDF)

Irinotecan Label (PDF)

Tamiflu AE - Reviewed (PDF)

Tamiflu Drug Use Review - Cleared (PDF)

Tamiflu Medical Review (PDF)

Tamiflu Clinical Pharmacology Summary (PDF)

Tamiflu Label (PDF)

Pediatric Safety Update for Tamiflu (PDF)

Reference List on Flue (PDF)

Tamiflu Executive Summary, Hoffmann-La Roche, Inc. (PDF)

Vioxx AE - Reviewed (PDF)

Vioxx BPCA Review - Cleared (PDF)

Vioxx Medical Review (PDF)

Vioxx Clinical Pharmacology Summary (PDF)

Vioxx Label (PDF)

Ferrlecit AE Reviewed (PDF)

Ferrlecit BPCA - Cleared (PDF)

Ferrlecit Clinical Review (PDF)

Ferrlecit Clinical Pharmacology Summary (PDF)

Ferrlecit Label (PDF)

Imitrex AE - Reviewed (PDF)

Imitrex Drug Use - Cleared (PDF)

Imitrex Clinical/Clinical Pharmacology and Biopharmaceutics Review (PDF)

Imitrex Spray Label (PDF)

Imitrex Tablet Label (PDF)