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U.S. Department of Health and Human Services

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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 Amendments 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 = 26

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)
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
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
Fludarabine - FludaraBerlexOriginal WR (PDF -82KB)Medical (PDF -502KB)NoneNone
Glimepiride - AmarylAventis Pharmaceuticals Inc.Original WR (PDF -169KB)
 
Medical (PDF -667KB)NoneStatistical (PDF -1MB)
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 4 (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
Metoprolol succinate - Toprol XLAstraZeneca LPOriginal WR (PDF -193KB)Medical (PDF -2.6MB)Clinical pharmacology (PDF -2.6MB
Addendum (PDF -1MB)
None
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)
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)
Salmeterol xinafoate - SereventGlaxoSmithKlineOriginal WR (PDF -258KB)
 
Medical (PDF -10.6MB)NoneStatistical (PDF -68KB)
Sibutramine hydrochloride monohydrate - Meridia New!Abbott LaboratoriesOriginal WR (PDF -292KBMedical (PDF -2.6MB)Clinical pharmacology (PDF -6MB)
Clinical pharmacology (PDF - 135KB)
Statistical (PDF -971KB)
Statistical (PDF - 207KB)
Sumatriptan - Imitrex New!GlaxoSmithKlineOriginal 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)