Advisory Committees
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Briefing Information for the June 23, 2009 Meeting of the Pediatric Advisory Committee
Food and Drug Administration
June 23, 2009
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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. � 552).
Cover Memo (June 23, 2009) (PDF - 22KB)Safety Concerns About Testosterone Gel
Androgel: May 8, 2009 FDA Press Release on Secondary ExposuresAndrogel: Safety Review Pediatric Cases (PDF - 174KB)Androgel: Safety Review Adult and Pediatric Cases (PDF - 113KB)Androgel: Case Review by Division of Reproductive/Urological Products (PDF - 75KB)Androgel: Case Review by Division of Metabolic Endocrine Products (PDF - 364KB)Androgel: Use Review (PDF - 101KB)Androgel: Clinical Review Summary of Pediatric Studies (PDF - 335KB)Androgel: Clinical Pharmacology Review Summary of Pediatric Studies (PDF - 57KB)Androgel: Labeling (PDF - 494KB)Depakote: Safety Review (PDF - 250KB)Depakote: Use Review (PDF - 79KB)Depakote: Division of Psychiatric Products Clinical Review of Pediatric Studies (7 pages) (PDF - 100KB)
Depakote: Division of Psychiatric Products Clinical Review of Pediatric Studies (7 pages)021168_Divalproex_Clinical(DNP)_BPCA.pdf (PDF - 2.1MB)
Depakote: Division of Neurology Products Clinical Review of Pediatric Studies (59 pages)021168_Divalproex_Clinical(DNP2)_BPCA.pdf (PDF - 352KB)
Depakote: Division of Neurology Products 2 Clinical Review Summary of Pediatric Studies (24 pages)022267_Divalproex_Clinical_PREA.pdf (PDF - 1.4MB)
Depakote: Clinical Review of Pediatric Studies (58 pages)021168_Divalproex_Clinpharm_BPCA.pdf (PDF - 100KB)
Depakote: Clinical Pharmacology Review of Pediatric Studies (10 pages)Depakote: Labeling (ER) (PDF - 640KB)Depakote: Labeling (sprinkles) (PDF - 604KB)Suicidal Behavior and Ideation and Antiepileptic Drugs
Depakote: Public Health Advisory Updated 5/5/2009Depakote: Additional Reference Information
Meador, K.J., G.A. Baker, et al. (2009). “Cognitive Function at 3 Years of Age After Fetal Exposure to Antiepileptic Drugs.” New England Journal of Medicine. 360(16): 1597-1609.Zometa: Safety Review (PDF - 119KB)Zometa: Use Review (PDF - 67KB)021223_Zoledronic_Acid_Clinical_BPCA.pdf (PDF - 1.9MB)
Zometa: Clinical Review Summary of Pediatric Studies (54 pages)021223_Zoledronic_Acid_Clinpharm_BPCA.pdf (PDF - 615KB)
Zometa: Clinical Pharmacology Review of Pediatric Studies (51 pages)021223_Zoledronic_Acid_Statistical_BPCA.pdf (PDF - 422KB)
Zometa: Statistical Review of Pediatric Studies (15 pages)Zometa: Labeling (PDF - 403KB)Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates
Zometa: FDA Alert Updated 11/12/2008Diovan: Safety Review (PDF - 129KB)Diovan: Use Review (PDF - 72KB)021283_Valsartan_Clinical_PREA.pdf (PDF - 1.2MB)
Diovan: Clinical/Statistical Full Review Combined of Pediatric Studies (49 pages)021283_Valsartan_ClinpharmBPCA.pdf (PDF - 10.1MB)
Diovan: Clinical Pharmacology Review of Pediatric Studies (86 pages)Diovan: Labeling (PDF - 182KB)Asmanex: Safety Review (PDF - 141KB)Asmanex: Use Review (PDF - 67KB)021067s003_Mometasone_Clinical_PREA.pdf (PDF - 3.8MB)
Asmanex: Clinical Review Summary of Pediatric Studies (199 pages)021067s003_Mometasone_Clinpharm_PREA.pdf (PDF - 595KB)
Asmanex: Clinical Pharmacology Review of Pediatric Studies (14 pages)021067s003_Mometasone_Statistical_PREA.pdf (PDF - 548KB)
Asmanex: Statistical Review of Pediatric Studies (26 pages)021067s003_Mometasone_Statistical2_PREA.pdf (PDF - 250KB)
Asmanex: Statistical 2 Review of Pediatric Studies (11 pages)Asmanex: Labeling (PDF - 568KB)Alvesco: Safety Review (PDF - 258KB)Alvesco: Use Review (PDF - 59KB)r_021658s000_Ciclesonide(Alvesco)_Clinical_PREA.pdf (PDF - 9.9MB)
Alvesco: Clinical Review Summary of Pediatric Studies (160 pages)r_021658s000_Ciclesonide(Alvesco)_Clinpharm_PREA.pdf (PDF - 1MB)
Alvesco: Clinical Pharmacology Review of Pediatric Studies (48 pages)r_021658s000_Ciclesonide(Alvesco)_Statistical_PREA.pdf (PDF - 300KB)
Alvesco: Statistical Review of Pediatric Studies (10 pages)Alvesco: Labeling (PDF - 363KB)Omnaris: Safety Review (PDF - 248KB)Omnaris: Use Review (PDF - 64KB)022124_Ciclesonide_Clinical_PREA.pdf (PDF - 1.6MB)
Omnaris: Clinical Review Summary of Pediatric Studies (65 pages)022124_Ciclesonide_Clinpharm_PREA.pdf (PDF - 165KB)
Omnaris: Clinical Pharmacology Review of Pediatric Studies (6 pages)022124_Ciclesonide_Statistical_PREA.pdf (PDF - 158KB)
Omnaris: Statistical Review of Pediatric Studies (8 pages)Omnaris: Labeling (PDF - 167KB)Combigan: Safety Review (PDF - 262KB)Combigan: Use Review (PDF - 78KB)021398s000_Brimonidine-timolol_clinical_PREA.pdf (PDF - 2.2MB)
Combigan: Clinical Review Summary of Pediatric Studies (47 pages)021398s000_Brimonidine-timolol_clinpharm_PREA.pdf (PDF - 137KB)
Combigan: Clinical Pharmacology Review of Pediatric Studies (4 pages)021398s000_Brimonidine-timolol_statistical_PREA.pdf (PDF - 716KB)
Combigan: Statistical Review of Pediatric Studies (17 pages)Combigan: Labeling (PDF - 800KB)Derma-Smoothe: Safety Review (PDF - 114KB)Derma-Smoothe: Use Review (PDF - 67KB)19452_Fluocinolone_Clinical_PREA.pdf (PDF - 943KB)
Derma-Smoothe: Clinical Review Summary of Pediatric Study (31 pages)19452_Fluocinolone_Clinpharm_PREA.pdf (PDF - 276KB)
Derma-Smoothe: Clinical Pharmacology Review of Pediatric Study (8 pages)19542_Fluocinolone_Statistical_PREA.pdf (PDF - 507KB)
Derma-Smoothe: Statistical Review of Pediatric Study (12 pages)Derma-Smoothe: Labeling (PDF - 137KB)Hepsera: Safety Review (PDF - 232KB)Hepsera: Use Review (PDF - 58KB)021449S011_Adefovir_Clinical_Review_BPCA (PDF - 1.4MB)
Hepsera: Clinical Review Summary of Pediatric Studies (50 pages)021449S011_Adefovir_Clinpharm_Review_BPCA (PDF - 634KB)
Hepsera: Clinical Pharmacology Review of Pediatric Studies (25 pages)021449S011_Adefovir_Statistical_Review_BPCA (PDF - 309KB)
Hepsera: Statistical Review of Pediatric Studies (18 pages)Hepsera: Labeling (PDF - 252KB)Inspra: Safety Review (PDF - 85KB)Inspra: Use Review (PDF - 59KB)021437S005_Eplerenone_Clinical_BPCA.pdf (PDF - 1.1MB)
Inspra: Clinical Review Summary of Pediatric Studies (31 pages)021437S005_Eplerenone_Clinpharm_BPCA.pdf (PDF - 798KB)
Inspra: Clinical Pharmacology Review of Pediatric Studies (49 pages)021437S005_Eplerenone_Statistical_BPCA.pdf (PDF - 338KB)
Inspra: Statistical Review of Pediatric Studies (12 pages)Inspra: Labeling (PDF - 381KB)Moxatag: Safety Review (PDF - 25KB)Moxatag: Use Review (PDF - 35KB)Moxatag: Labeling (PDF - 317KB)050813s000_Amoxicillin_Clinical_PREA (PDF - 3MB)
Moxatag: Clinical Review Summary of Pediatric Studies (132 pages)050813s000_Amoxicillin_Clinpharm_PREA.pdf (PDF - 751KB)
Moxatag: Clinical Pharmacology Review of Pediatric Studies (48 pages)050813s000_Amoxicillin_Statistics_PREA.pdf (PDF - 1.2MB)
Moxatag: Statistical Review of Pediatric Studies (54 pages)Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Handout: Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)Information Pertaining to Labeling Revision for Gardasil
Handout: Information Pertaining to Labeling Revision for GardasilHandout: 100 Pediatric Safety Reviews Presented to the Pediatric Advisory Committee or Subcommittee from June 2003 to June 2009 (PDF - 44KB)
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Briefing Materials - Sponsors
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.
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