Advisory Committees
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Briefing Information for the March 22, 2010 Meeting of the Pediatric Advisory Committee
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Briefing Materials - FDA
Disclaimer: Portions of these documents have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. Sec. 552).
Cover Memo (March 22, 2010) (PDF - 30KB)Topical Calcineurin Inhibitors: Safety Review (PDF - 374KB)Topical Calcineurin Inhibitors: Safety Review - Addendum (PDF - 63KB)Topical Calcineurin Inhibitors: Use Review (PDF - 298KB)Topical Calcineurin Inhibitors: Abstract Reference Information Topical Calcineurin Inhibitors: Protopic Labeling 
Topical Calcineurin Inhibitors: Meeting Minutes and Recommendations from 2005 PAC Meeting (PDF - 89KB)Vaccine Background Reference Information Daptacel: Safety and Use Review (PDF - 103KB)Clinical Review - DAPTACEL (PDF - 178KB)
Daptacel: Clinical Review Summary of Pediatric StudiesPackage Insert - DAPTACEL (PDF - 217KB)
Daptacel: Package InsertPentacel: Safety and Use Review (PDF - 71KB)Clinical Review (PDF - 1.4MB)
Pentacel: Clinical Review Summary of Pediatric StudiesStatistical Review and Evaluation (PDF - 188KB)
Pentacel: Statistical Review of Pediatric StudiesPackage Insert - Pentacel (PDF - 327KB)
Pentacel: Package InsertKinrix: Safety and Use Review (PDF - 76KB)Clinical Review - Kinrix (PDF - 747KB)
Kinrix: Clinical Review Summary of Pediatric StudiesStatistical Review and Evaluation-Kinrix (PDF - 271KB)
Kinrix: Statistical Review of Pediatric StudiesRotarix: Safety and Use Review (PDF - 62KB)Clinical Review for STN 125265/0 Rotarix: Rotavirus Vaccine, Live, Oral (PDF - 4.5MB)
Rotatrix: Clinical Review Summary of Pediatric StudiesStatistical Review and Evaluation - Rotarix
Rotarix: Statistical Review and EvaluationRotatrix: Additional Reference Information #1
Rotatrix: Additional Reference Information #2
Package Insert and Patient Information - Rotarix (PDF - 182KB)
Rotarix: Package InsertRotarix: Labeling Change Information Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
Rotarix: FDA News Release - March 22, 2010Valtrex: Safety Review (PDF - 199KB)Valtrex: Use Review (PDF - 74KB)020487s014s015_Valacyclovir_Clinical_BPCA.pdf (PDF - 719KB)
Valtrex: Clinical Review Summary of Pediatric Studies020487s014_Valacyclovir_Clinpharm_BPCA.pdf (PDF - 506KB)
Valtrex: Clinical Pharmacology ReviewValtrex: Labeling
Zmax: Safety Review (PDF - 153KB)Zmax: Addendum Memo (PDF - 20KB)Zmax: Maternal Health Team Review (PDF - 146KB)Zmax: Use Review (PDF - 90KB)050797s008_Azithromycin_Clinical_PREA.pdf (PDF - 76KB)
Zmax: Clinical Review Summary of Pediatric Studies050797s008_Azithromycin_Clinpharm_PREA.pdf (PDF - 67KB)
Zmax: Clinical Pharmacology Review of Pediatric StudiesViramune: Safety Review (PDF - 456KB)Viramune: Use Review (PDF - 57KB)020933_20636_Nevirapine_Clinical_PREA.pdf (PDF - 1.3MB)
Viramune: Clinical Review of Pediatric Studies020933_20635_Nevirapine_Clinpharm_PREA.pdf (PDF - 968KB)
Viramune: Clinical Pharmacology Review of Pediatric StudiesViramune: Link to WHO Guidelines on Prevention of Maternal Child Transmission of HIV #1
Viramune: Link to WHO Guidelines on Prevention of Maternal Child Transmission of HIV #2
Viramune: Labeling
Nasacort AQ: Safety Review (PDF - 150KB)Nasacort AQ: Use Review (PDF - 50KB)020468s024_Triamcinolone_Clinical_PREA.pdf (PDF - 1.2MB)
Nasacort AQ: Clinical Review Summary of Pediatric Studies020468s024_Triamcinolone_Clinpharm_PREA.pdf (PDF - 810KB)
Nasacort AQ: Clinical Pharmacology Review of Pediatric Studies020468s024_Triamcinolone_Statistical_PREA.pdf (PDF - 615KB)
Nasacrot AQ: Statistical Review of Pediatric StudiesNasacort AQ: Labeling
Cardiolite: Use Review (PDF - 73KB)Cardiolite: Safety Review (PDF - 85KB)019785s018_Technetium_Clinical_BPCA.pdf (PDF - 561KB)
Cardiolite: Clinical Review Summary of Pediatric Studies019785s018_Technetium_Clinpharm_BPCA.pdf (PDF - 571KB)
Cardiolite: Clinical Pharmacology Review of Pediatric Studies019785s018_Technetium_Statistical_BPCA.pdf (PDF - 357KB)
Cardiolite: Statistical Review of Pediatric StudiesAnthelios 40: Safety Review (PDF - 39KB)Anthelios 40: Summary of Pediatric Safety Data for OTC Approval (PDF - 83KB)022009_Ecamsule-Anthelios_Clinical_PREA_june.pdf (PDF - 3.9MB)
Anthelios 40: Clinical Review Summary of Pediatric Study022009_Ecamsule-Anthelios_ClinPharm_PREA_june.pdf (PDF - 2MB)
Anthelios 40: Clinical Pharmacology Review of Pediatric StudyAnthelios 40: Labeling (PDF - 650KB)Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical) [ARCHIVED]
Orlistat: Early CommunicationOrlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
Orlistat: Early Communication about Ongoing Safety ReviewOrlistat: Additional Reference Information February 14, 2005 PAC Orlistat Presentation Slides April 11, 2007 PAC Orlistat Presentation Slides Orlistat: Labeling (PDF - 318KB)
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Open Public Hearing
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