Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)

In accordance with section 504 of FDASIA (Public Law 112-144), the following are the Written Requests issued under 505A(b) or (c) of the Act, and the medical, clinical pharmacology, and statistical reviews of pediatric studies conducted in response to that Written Request. These studies were submitted between January 4, 2002, and September 27, 2007; six months of pediatric exclusivity was granted; and the studies resulted in a label change.

Total Number of Products Studied under BPCA = 42

DrugSponsorWritten RequestMedical ReviewClinical Pharmacology ReviewStatistical Review
Alendronate sodium - FosamaxMerck & Co., Inc.Original WR (PDF -410KB)
Amendment (PDF -206KB)
Medical (PDF -1.5MB)Clinical pharmacology (PDF -1.7MB)Statistical (PDF -1003KB)
Anagrelide hydrochloride - AgrylinShire Pharmaceutical Development Inc.Original WR (PDF -466KB)
Amendment (PDF -447KB) )
Amendment 2 (PDF -310KB)
Medical (PDF -2MB)Clinical pharmacology (PDF -472KB)None
Aripiprazole - AbilifyOtsuka Pharmaceutical Company, LtdOriginal WR (PDF -251KB)
Medical (PDF -2.3MB)Clinical pharmacology (PDF -385KB)Statistical (PDF -251KB)
Benazepril hydrochloride - LotensinNovartis Pharmaceuticals CorporationOriginal WR (PDF -363KB)
Amendment (PDF -416KB)
Medical (PDF -1MB)Clinical pharmacology (PDF -1.9MB)Statistical (PDF -590KB)
Betaxolol hydrochloride ophthalmic suspension - Betoptic SAlcon Laboratories, Inc.Original WR (PDF -276KB)Medical (PDF -1.7MB)
Medical (PDF -83KB)
Budesonide inhalation suspension - Pulmicort RespulesAstraZeneca PharmaceuticalsOriginal WR (PDF -352KB)
Amendment (PDF -153KB)
Amendment 2 (PDF -120KB)
Amendment 3 (PDF -139KB)
Amendment 4 (PDF -62KB)
Amendment 5 (PDF -132KB)
Medical (PDF -1.8MB)NoneNone
Citalopram - CelexaForest LabsOriginal WR (PDF -414KB)
Medical (PDF -305KB)
Clinical pharmacology (PDF -7.5MB)None
Clofarabine - ClolarGenzyme CorporationOriginal WR (PDF -162KB)
Amendment (PDF -301KB)
Medical (PDF -1.7MB)Clinical pharmacology (PDF -165KB)Statistical (PDF -1.7MB)
Emtricitabine - EmtrivaGilead Sciences, IncOriginal WR (PDF -218KB)Medical (PDF -453KB)Clinical pharmacology (PDF -1.4MB)Statistical (PDF -703KB)
Fenoldopam mesylate - CorlopamAbbott LaboratoriesNoneMedical (PDF -2.2MB)Clinical pharmacology (PDF -3.5MB)None
Fentanyl Transdermal System - DuragesicAlza CorporationOriginal WR (PDF -189KB)
Amendment (PDF -105KB)
Amendment 1 (PDF -192KB)
Medical (PDF -3MB)Clinical pharmacology (PDF -997KB)None
Fexofenadine HCL - Allegra New!Aventis Pharmaceuticals, Inc.Original WR (PDF -144KB)
Amendment (PDF -270KB)
Medical (PDF -10MB)Clinical pharmacology (PDF -3MB)None
Fluvastatin sodium - LescolNovartis Pharmaceuticals CorporationOriginal WR (PDF -166KB)Medical (PDF - 1.2MB)NoneStatistical (PDF -866KB)
Fludarabine - FludaraBerlexOriginal WR (PDF -82KB)Medical (PDF -502KB)NoneNone
Glimepiride - AmarylAventis Pharmaceuticals Inc.Original WR (PDF -169KB)
Medical (PDF -667KB)NoneStatistical (PDF -1MB)
Insulin aspart - NovoLogNovo Nordisk Inc.Original WR (PDF -349KB)
Amendment (PDF -145KB)
Amendment 2 (PDF -198KB)
Amendment 3 (PDF -295KB)
Amendment 6 (PDF -316KB)
Medical (PDF -898KB)NoneStatistical (PDF -526KB)
Irbesartan - AvaproBristol-Myers SquibbOriginal WR (PDF -551KB)Medical (PDF -1.2MB)Clinical pharmacology (PDF -6.7MB)Statistical (PDF -441KB)
Irinotecan hydrochloride - CampostarPfizer IncOriginal WR (PDF -276KB)Medical (PDF -4.6MB)Clinical pharmacology (PDF -4.5MB)None
Gemcitabine hydrochloride - GemzarEli Lilly and CompanyOriginal WR (PDF -280KB)NoneNoneNone
Lamotrigine - LamictalSmithKlineBeechamOriginal WR (PDF -319KB)Medical (PDF -5.6MB)Clinical pharmacology (PDF -4MB)None
Lansoprazole - PrevacidTAP Pharmaceutical Products Inc.Original WR (PDF 316KB)
Amendment (PDF -246KB)
Amendment 2 (PDF -125KB)
Amendment 3 (PDF -163KB
Amendment 6 (PDF -604KB)
Medical (PDF -3.5MB)Clinical pharmacology (PDF -432KB)Statistical (PDF -580KB)
Leflunomide - AravaAventis Pharmaceuticals Inc.Original WR (PDF -324KB)NoneClinical pharmacology (PDF - 236KB)None
Levobetaxolol hydrochloride ophthalmic suspension - BetaxonAlcon Research, Ltd.Original WR (PDF -962KB)Medical (PDF -124KB)NoneNone
Levofloxacin - LevaquinOrtho-McNeil Pharmaceutical, Inc.c/o Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Original WR (PDF -141KB)
Amendment (PDF -158KB)
Amendment 2 (PDF -188KB)
Medical (PDF -1MB)Clinical pharmacology (PDF -174KB)
Clinical pharmacology 2 (PDF -1.7MB)
Clinical pharmacology review (PDF -178KB)
Statistical (PDF -71KB)
Metoprolol succinate - Toprol XLAstraZeneca LPOriginal WR (PDF -193KB)Medical (PDF -2.6MB)Clinical pharmacology (PDF -2.6MB
Addendum (PDF -1MB)
Modafinil - ProvigilCephalon, Inc.Original WR (PDF -294KB)
Medical (PDF -3.8MB)Clinical pharmacology (PDF -1.6MB)Statistical (PDF -179KB)
Nefazodone hydrochloride - SerzoneBristol-Myers Squibb CompanyOriginal WR (PDF -443KB)
Medical (PDF -1.3MB)Clinical pharmacology (PDF -1MB)None
Norgestimate/Ethinyl estradiol - Ortho Tri-CyclenOrtho-McNeil Pharmaceutical, Inc.Original WR (PDF -170KB)
Amendment (PDF -182KB)
Amendment 2 (PDF -309KB)
Medical (PDF -260MB)Clinical pharmacology (PDF -1.4MB)Statistical (PDF -1.4MB)
Octreotide acetate - Sandostatin Lar Depot InjectionNovartis Pharmaceuticals CorporationOriginal WR (PDF -230KB)
Medical (PDF -2.2MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -1.2MB)
Oseltamivir phosphate - TamifluHoffmann-La Roche Inc.Original WR (PDF -175KB)
Amendment (PDF -251KB)
Medical (PDF -292KB)NoneNone
Oxybutynin chloride - Ditropan XLJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Original WR (PDF -200KB)Medical (PDF -2.9MB)Clinical pharmacology (PDF -380KB)None
Paricalcitol - ZemplarAbbott LaboratoriesOriginal WR (PDF -188KB)
Amendment (PDF -151KB)
Medical (PDF -538KB)NoneStatistical (PDF -914KB)
Paroxetine hydrochloride - PaxilGlaxoSmithKlineOriginal WR (PDF -495KB)
Amendment (PDF -236KB)
Medical (PDF -3.2MB)Clinical pharmacology (PDF -1MB)None
Risperidone - RisperdalJohnson & Johnson PR&DOriginal WR (PDF -340KB)Medical (PDF -2.5MB)Clinical pharmacology (PDF -2MB)
Clinical pharmacology (PDF - 141KB)
Statistical (PDF -441KB)
Ritonavir - NorvirAbbott LaboratoriesOriginal WR (PDF -162KM)
Amendment (PDF -238KB)
Medical (PDF -256KB)Clinical pharmacology (PDF -752KB)None
Salmeterol xinafoate - SereventGlaxoSmithKlineOriginal WR (PDF -258KB)
Medical (PDF -10.6MB)NoneStatistical (PDF -68KB)
Sertraline hydrochloride - ZoloftPfizer Inc.Original WR (PDF -285KB)
Amendment (PDF -196KB)
Medical (PDF -2MB)NoneStatistical (PDF -230KB)
Sibutramine hydrochloride monohydrate - MeridiaAbbott LaboratoriesOriginal WR (PDF -292KBMedical (PDF -2.6MB)Clinical pharmacology (PDF -6MB)
Clinical pharmacology (PDF - 135KB)
Statistical (PDF -971KB)
Statistical (PDF - 207KB)
Sodium ferric gluconate complex in sucrose - FerrlecitWatson Pharma, Inc.Original WR (PDF -188KB)Medical (PDF -1.2MB)Clinical pharmacology (PDF -1.1MB)Statistical (PDF -174KB)
Sumatriptan - ImitrexGlaxoSmithKlineOriginal WR (PDF -271KB)
Amendment (PDF -134KB)
Amendment 2 (PDF -119KB)
Medical (PDF -2MB)Clinical pharmacology (PDF -445KB)Statistical (PDF -378KB)
Venlafaxine - Effexor XRWyeth Pharmaceuticals, Inc.Original WR (PDF -396KB)
Amendment (PDF -158KB)
Medical (PDF -2MB)Clinical pharmacology (PDF -3MB)Statistical (PDF -172KB)
Zolmitriptan - ZomigAstraZeneca Pharmaceuticals LPOriginal WR (PDF -324KB)
Amendment (PDF -127KB)
Medical (PDF -5.8MB)
Medical (PDF -1.8MB)
Clinical pharmacology (PDF -903KB)Statistical (PDF -393KB)


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