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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 Exposures - Androgel: 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)
- 021168_Divalproex_Clinical(DPP)_BPCA.pdf (PDF - 100KB)
Depakote: Division of Psychiatric Products Clinical Review of Pediatric Studies (7 pages) - 021168_Divalproex_Clinical(DNP)_BPCA.pdf (PDF - 2193KB)
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 - 1430KB)
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 5/5/2009 - Depakote: 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 - 1919KB)
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 11/12/2008 - Diovan: Safety Review (PDF - 129KB)
- Diovan: Use Review (PDF - 72KB)
- 021283_Valsartan_Clinical_PREA.pdf (PDF - 1239KB)
Diovan: Clinical/Statistical Full Review Combined of Pediatric Studies (49 pages) - 021283_Valsartan_ClinpharmBPCA.pdf (PDF - 10295KB)
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 - 3882KB)
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 - 10124KB)
Alvesco: Clinical Review Summary of Pediatric Studies (160 pages) - r_021658s000_Ciclesonide(Alvesco)_Clinpharm_PREA.pdf (PDF - 1037KB)
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 - 1664KB)
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 - 2210KB)
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 - 1432KB)
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 - 1080KB)
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 - 3113KB)
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 - 1183KB)
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 Gardasil - Handout: 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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