Drugs

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 = 75

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)
Balsalazide disodium - ColazalSalix Pharmaceuticals, IncOriginal WR (PDF -169KB)Medical (PDF -3.3MB)Clinical pharmacology (PDF -708KB)Statistical (PDF -509KB)
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)
NoneNone
Brinzolamide - Azopt Alcon Research, Ltd.Original WR (PDF -962KB)Medical (PDF -124KB)NoneNone
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
Carvedilol - Coreg  SmithKline Beecham Corporation d/b/a GlaxoSmithKlineOriginal WR (PDF -307KB)
Amendment (PDF -160KB)
Amendment 2 (PDF -292KB)
Amendment 3 (PDF -200KB)
Amendment 4 (PDF -183KB)
Amendment 5 (PDF -273KB)
Medical (PDF -1.6MB)Clinical pharmacology (PDF -1.2MB)Statistical (PDF -330KB)
Celecoxib - Celebrex G.D. Searle L.L.C.Original WR (PDF -176KB)
Amendment (PDF -180KB)
Amendment 2 (PDF -88KB)
Amendment 3 (PDF -627KB)
Amendment 4 (PDF -184KB)
Amendment 5 (PDF -194KB)
Medical (PDF -3.8MB)Clinical pharmacology (PDF -6MB)Statistical (PDF -846KB)
Ciprofloxacin hydrochloride - CiproBayer Pharmaceuticals CorporationOriginal WR (PDF -883KB)
Amendment (PDF -676KB)
Amendment 2 (PDF -740KB)
Medical (PDF -6.8MB)Clinical pharmacology (PDF -1.6MB)Statistical (PDF -2.9MB)
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)
Desflurane USP - SupraneBaxter Healthcare CorporationOriginal WR (PDF -678KB)
Amendment (PDF -305KB)
Amendment 2 (PDF -65KB)
Medical (PDF -1.2MB)NoneNone
Dorzolamide hydrochloride ophthalmic solution -TrusoptMerck & Co., Inc.Original WR (PDF -265KB)
Amendment (PDF -167KB)
Amendment 2(PDF -120KB)
Medical (PDF -2.9MB)NoneStatistical (PDF -581KB)
Emtricitabine - EmtrivaGilead Sciences, IncOriginal WR (PDF -218KB)Medical (PDF -453KB)Clinical pharmacology (PDF -1.4MB)Statistical (PDF -703KB)
Ertapenem - Invanz  MerckOriginal WR (PDF -267KB)Medical (PDF -2.9MB)Clinical pharmacology (PDF -4MB)Statistical (PDF -1.4MB)
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 - AllegraAventis Pharmaceuticals, Inc.Original WR (PDF -144KB)
Amendment (PDF -270KB)
Medical (PDF -10MB)Clinical pharmacology (PDF -3MB)None
Fludarabine - FludaraBerlexOriginal WR (PDF -82KB)Medical (PDF -502KB)NoneNone
Fluticasone propionate - FlonaseGlaxoSmithKlineOriginal WR (PDF -754KB)
Amendment (PDF -331KB)
Amendment 2 (PDF -133KB)
Medical (PDF -12MB)
DD Summary review (PDF -286KB)
TL Summary review (PDF -1MB)
Clinical pharmacology (PDF -1MB)
Clinical pharmacology (PDF -106KB)
Statistical (PDF 70KB)
Fluticasone propionate - Flovent GlaxoSmithKlineOriginal WR (PDF -754KB)
Amendment (PDF -331KB)
Amendment 2 (PDF -133KB)
Medical (PDF -12MB)
DD Summary review (PDF -286KB)
TL Summary review (PDF -1MB)
Clinical pharmacology (PDF -1MB)
Clinical pharmacology (PDF -106KB)
Statistical (PDF 70KB)
Fluvastatin sodium - LescolNovartis Pharmaceuticals CorporationOriginal WR (PDF -166KB)Medical (PDF - 1.2MB)NoneStatistical (PDF -866KB)
Fosinopril - Monopril Bristol-Myers SquibbOriginal WR (PDF -250KB)
Amendment (PDF -241KB)
Medical (PDF -1.1MB)NoneStatistical (PDF -282KB)
Gemcitabine hydrochloride - GemzarEli Lilly and CompanyOriginal WR (PDF -280KB)NoneNoneNone
Glimepiride - AmarylAventis Pharmaceuticals Inc.Original WR (PDF -169KB)
 
Medical (PDF -667KB)NoneStatistical (PDF -1MB)
Glyburide and metformin HCl - GlucovanceBristol-Myers SquibbOriginal WR (PDF -213KB)
Amendment (PDF -123KB)
Amendment 2 (PDF -323KB)
Amendment 3 (PDF -185KB)
Amendment 4 (PDF -191KB)
Medical (PDF -1.1MB)NoneStatistical (PDF -655KB)
Imatinib - Gleevec Novartis Pharmaceuticals CorporationOriginal WR (PDF -215KB)Medical (PDF -574KB)Clinical pharmacology (PDF -566KB)Statistical (PDF -574KB)
Imiquimod - AldaraGraceway Pharmaceuticals, LLCOriginal WR (PDF -162KB)
Amendment (PDF -263KB)
Amendment 2 (PDF -173KB)
Amendment 3 (PDF -240KB)
Amendment 4 (PDF 141KB)
Medical (PDF -2.7MB)Clinical pharmacology (PDF -1.2MB)Statistical (PDF -978KB)
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
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
Levetiracetam - KeppraUCB Pharma, Inc.Original WR (PDF -14MB)
Amendment (PDF -197MB)
Medical (PDF -3.4MB)Clinical pharmacology (PDF -8.3MB)Statistical (PDF -9.5KB)
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)
Linezolid - ZyvoxPharmacia & Upjohn, Inc.Original WR (PDF -226KB)
Amendment (PDF -638KB)
Amendment 2 (PDF -395KB)
Amendment 3 (PDF -504KB)
Amendment 4 (PDF -470KB)
Medical (PDF -1MB)Clinical pharmacology (PDF -227KB)None
Meloxicam - MobicBoehringer Ingelheim Pharmaceuticals, Inc.Original WR (PDF -320KB)Medical (PDF -2.2MB)NoneStatistical (PDF -3MB)
Methylphenidate HCL - ConcertaMcNeil Consumer & Specialty PharmaceuticalsOriginal WR (PDF -178KB)
Amendment (PDF -343KB)
Medical (PDF -1.8MB)Clinical pharmacology (PDF -4.5MB)Statistical (PDF -1.1MB)
Metoprolol succinate - Toprol XLAstraZeneca LPOriginal WR (PDF -193KB)Medical (PDF -2.6MB)Clinical pharmacology (PDF -2.6MB
Addendum (PDF -1MB)
None
Mixed salts of a single-entity amphetamine product - Adderall XRShire Development, Inc.Original WR (PDF -356KB)
Amendment (PDF -342KB)
Amendment 2 (PDF -308KB)
Medical (PDF -4.9MB)Clinical pharmacology (PDF -11MB)Statistical (PDF -1.1MB)
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
Nelfinavir mesylate - ViraceptAgouron Pharmaceuticals Inc.

Original WR (PDF - 346KB)

Amendent (PDF -110KB)

Medical (PDF -6.7MB)Clinical pharmacology (PDF -2.9MB)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)
Ofloxacin ophthalmic solution - Ocuflox  New!Allergen Inc.Original WR (PDF -141KB)
 
Medical (PDF -648KB)
Medical (PDF -540KB)
NoneNone
Olanzapine - ZyprexaEli Lilly and CompanyOriginal WR (PDF -111KB)
 
Medical (PDF -5.8MB)
Medical (PDF -500KB)
Clinical pharmacology (PDF -1.8MB)
Clinical pharmacology (PDF -551KB)
Statistical (PDF -394KB)
Ondansetron hydrochloride - ZofranGlaxoSmithKlineOriginal WR (PDF -175KB)
Amendment (PDF -303KB))
Amendment 2 (PDF -320KB)
Medical (PDF -5.8MB)Clinical pharmacology (PDF -2.6MB)Statistical (PDF -561KB)
Orlistat - XenicalHoffmann-La Roche, Inc.Original WR (PDF -329KB)Medical (PDF -1.7MB)Clinical pharmacology (PDF -650KB)Statistical (PDF -670KB)
Oseltamivir phosphate - TamifluHoffmann-La Roche Inc.Original WR (PDF -175KB)
Amendment (PDF -251KB)
Medical (PDF -292KB)NoneNone
Oxaliplatin – EloxatinSanofi-AventisOriginal WR (PDF -679KB)
Amendment (PDF -283KB)
Medical (PDF -2.5MB)Clinical pharmacology (PDF -4MB)Statistical (PDF -1.2MB)
Oxcarbazepine - Trileptal Novartis Pharmaceuticals CorporationOriginal WR (PDF -230KB)Medical (PDF -2.1MB)Clinical pharmacology (PDF -1.5MB)Statistical (PDF -934KB)
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
Rofecoxib - VioxxMerck & Co., IncOriginal WR (PDF -259KB)
Amendment (PDF -182KB)
Amendment 2 (PDF -196KB)
Medical (PDF -6.8MB)
DD (PDF -577KB)
DD2 (PDF -921KB)
CTDL (PDF -765KB)
Clinical pharmacology (PDF -3.5MB )
Clinical pharmacology (PDF -776KB)
Statistical (PDF -2.2MB)
Rosiglitazone - AvandiaSB Pharmco Puerto Rico, Inc. (d/b/a GlaxoSmithKline)Original WR (PDF -213KB)
Amendment (PDF -176KB)
Amendment 2 (PDF -323KB
Medical (PDF -3.1MB)NoneStatistical (PDF -2.5MB)
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)
Sirolimus - RapamuneWyeth Pharmaceuticals, Inc.Original WR (PDF -234KB)Medical (PDF -2.4KB)Clinical pharmacology (PDF -106KB)Statistical (PDF -422KB)
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)
Temozolomide - TemodarSchering CorporationOriginal WR (PDF -196KB)
Amendment (PDF -123KB)
Medical (PDF -4.2MB)Clinical pharmacology (PDF -1MB)Statistical (PDF -1.5MB)
Testosterone gel - AndroGel PDSolvay Pharmaceuticals, Inc. on behalf of Unimed Pharmaceuticals, Inc.Original WR (PDF -171KM)
Amendment (PDF -683KB)
Medical (PDF -8.9MB)Clinical pharmacology (PDF -5.7MB)
Clinical pharmacology (PDF -93KB)
Statistical (PDF -817KB)
Testosterone gel - AndroGel PDSolvay Pharmaceuticals, Inc. on behalf of Unimed Pharmaceuticals, Inc.Original WR (PDF -171KM)
Amendment (PDF -683KB)
Medical (PDF -8.9MB)Clinical pharmacology (PDF -5.7MB)
Clinical pharmacology (PDF -93KB)
Statistical (PDF -817KB)
Tolterodine tartrate - Detrol LA  Pfizer IncorporatedOriginal WR (PDF -613KB)
Amendment (PDF -638KB)
Amendment 2 (PDF -148KB)
Amendment 3 (PDF -118KB)
Medical (PDF -601MB)
Medical (PDF -10.6MB)
Clinical pharmacology (PDF -3.3MB)Statistical (PDF -2MB)
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)
Zolpidem tartrate - AmbienSanofi-aventis, U.S. Inc.Original WR (PDF -186KB)Medical (PDF -3MB)Clinical pharmacology (PDF -436KB)None

 

Page Last Updated: 07/02/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.