Drugs

Written Requests Issued

  

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act

NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since June 1998. If a product appears on this list, it does not imply that studies have been conducted or submitted to the Agency, nor does it mean that the studies described in the Written Request will be conducted. A sponsor is NOT required to perform pediatric studies in response to a Written Request. Conducting pediatric studies in response to a Written Request is voluntary. Upon occasion, information obtained by FDA subsequent to issuance of a Written Request causes FDA to rescind the Written Request. This list is not updated to indicate when a Written Request has been rescinded.
 

Total Approved Active Moieties Issued a Written Request = 426*
Active Moiety
Sponsor
AbacavirGlaxo Wellcome, Inc.
AbataceptBristol-Myers Squibb Company
AcamprosateForest Labs
Acetaminophen Cadence Pharmaceuticals
AcetazolamideWyeth-Ayerst
AdefovirGilead
AlbuterolDey
AlbuterolGlaxoSmithKline
AlendronateMerck
AlfuzosinSanofi-Aventis U.S. LLC
AliskirenNovartis
AlmotriptanPharmacia & Upjohn
AlogliptinTakeda Pharmaceuticals U.S.A., Inc.
AlosetronGlaxo Wellcome, Inc.
AlprazolamPharmacia & Upjohn
AmiodaroneWyeth Ayerst
AmlexanoxBlock Drug
AmlodipinePfizer, Inc.
Amlodipine/BenazeprilNovartis
Ammonium LactateWestwood Squibb
Amphetamine (mixed salts)Shire
AmprenavirGlaxo Wellcome, Inc.
AnagrelideShire
AnastrozoleAstraZeneca
ApremilastCelgene Corporation
Aprepitant/FosaprepitantMerck & Company, Inc.
ArgatrobanEncysive
AripiprazoleOtsuka
AsenapineOrganon USA, Inc.
AtazanavirBristol-Myers Squib
Atezolizuab the word new in a red boxGenentech, Inc.
AtomoxetineLilly
AtorvastatinWarner-Lambert
Atovaquone/ProguanilGlaxo Wellcome, Inc.
AzelastineASTA Medica
AzelastineMeda Pharmaceuticals, Inc.
Azilsartan medoxomilTakeda Pharmaceuticals U.S.A., Inc.
Azithromycin Pfizer
BaclofenSchwarz
BalsalazideSalix Pharm.
BeclomethasoneSchering
Beclomethasone3M
BenazeprilNovartis
BendamustineCephalon, Inc.
BesifloxacinBausch & Lomb, Inc.
BetamethasoneSchering
BetaxololLorex Pharmaceuticals
BetaxololAlcon
BicalutamideAstraZenenca Pharm.
BisoprololWyeth-Ayerst
BivalirudinMeds Co.
Boceprevir Schering-Plough
BortezomibMillenium Pharm
BosutinibWyeth Pharmaceuticals, Inc.
BrimonidineAllergan, Inc.
BrinzolamideAlcon
BudesonideAstraZeneca
Budesonide/FormoterolAstraZeneca
BuprenorphineReckitt Benckiser Pharm
BuproprionGlaxo Wellcome, Inc
BuspironeBristol-Myers Squibb
BusulfanOrphan Medical
C-UreaMeretek
Cabazitaxel Sanofi-Aventis
CalcipotrieneLeo Pharm
CalcitriolAbbott
CalcitriolGalerma Laboratories
CanagliflozinJanssen Pharmaceuticals, Inc.
CandesartanAstra Pharmaceuticals
CapecitabineHLR
CarbamazepineShire
CarboplatinBristol-Myers Squibb
CarfilzomibOnyx Therapeutics, Inc.
CarteololCIBA
CarvedilolSmithKline Beecham
CaspofunginMerck
CelecoxibSearle
CerivastatinBayer
CetirizinePfizer
CilostazolOtsuka
CimetidineSmithKline Beecham
CinacalcetAmgen, Inc.
CiprofloxacinBayer
CiprofloxacinAlcon
CisatracuriumGlaxo Wellcome
CitalopramForest Laboratories, Inc.
ClobazamLundbeck, LLC
ClofarabineILEX Products, Inc.
ClopidogrelSanofi-Synthelabo
CobicistatGilead Sciences, Inc.
Colchicine, USPAR Holding Co., Inc.
ColesevelamSankyo Pharma
ConivaptanAstrellas Pharma
Crizotinib Pfizer, Inc.
CromolynPharmacia & Upjohn
CromolynBausch & Lomb
CysteamineRaptor Therapeutics, Inc.
CytarabineSkyePharma Inc.
DabrafenibNovartis Pharmaceuticals Corporation
DactinomycinMerck & Company, Inc.
DapsoneAllergan, Inc.
DaptomycinCubist Pharmaceuticals, Inc.
DarbepoetinAmgen, Inc.
DarifenacinNovartis Pharmaceuticals Corp.
DarunavirTibotec, Inc.
DasatinibBMS
DecitabineEisai medical Research, Inc.
DeferasiroxNovartis Pharmaceuticals Corporation
DenosumabAmgen, Inc.
DesfluraneBaxter Healthcare
DesloratadineSchering
DesvenlafaxineWyeth
DexmedetomidineHospira, Inc.
DexmethylphenidateNovartis Pharm
DexrazoxanePfizer Pharm
DichlorphenamideMerck
DiclofenacNovartis
Diclofenac Xanodyne Pharm
DidanosineBristol-Myers Squibb
DifluprednateSirion Therapeutics, Inc.
DihydroergotamineValeant
DivalproexAbbott Laboratories
Divalproex (valproate)Abbott Laboratories
DocetaxelSanofi-Aventis, U.S., Inc.
DolutegravirViiV Healthcare
DorzolamideMerck
DuloxetineEli Lilly & Co.
Dulaglutide the word new in a red boxEli Lilly & Co.
EfavirenzDuPont Pharmaceutical Company
EfinaconazoleDow Pharmaceuticals Sciences
EletriptanPfizer, Inc.
EltrombopagGlaxoSmithKline
ElvitegravirGilead Sciences, Inc.
EmtricitabineTriangle Pharmaceuticals
EnalaprilMerck
EnfuvirtideHoffman-La Roche
EnoxaparinAventis
EntecavirBMS
EpirubicinPharmacia & Upjohn
EplerenoneSearle
Eribulin       Eisai, Inc.
ErlotinibOSI Pharm
ErtapenemMerck
EslicarbazapineSunovion Pharmaceutical, Inc.
EsmololBaxter Pharmaceutical
EsomeprazoleAstraZeneca
EszopicloneSepracor
EtodolacWyeth-Ayerst
EtravirineTibotec, Inc.
EverolimusNovartis
ExenatideAmylin Pharmaceuticals
EzetimibeMSP Singapore
FamciclovirNovartis
FamotidineMerck
FelodipineAstra Pharmaceuticals
FenoldopamElan Pharmaceuticals
FentanylAnesta
FentanylJanssen Pharmaceutica
Ferric CitrateKeryx Biopharmaceuticals, Inc.
Fesoterodine Pfizer, Inc.
FexofenadineAventis
FingolimodNovartis Pharmaceutical Corporation
FluconazolePfizer
FludarabineBerlex
FluocinoloneBausch & Lomb
FluoxetineLilly
FluticasoneGlaxo Wellcome, Inc.
FluvastatinNovartis
FluvoxamineSolvay Pharmaceuticals
FormoterolNovartis
FosamprenavirGlaxoSmithKline
FosaprepitantMerck
FosinoprilBristol-Myers Squibb
FosphenytoinPfizer
Fospropofol Eisai, Inc.
FulvestrantAstraZeneca Pharmaceut
GadopentetateBayer Health Care Pharm, Inc.
GabapentinParke-Davis
GatifloxacinBristol-Myers Squibb
GatifloxacinAllergan
GefitinibAstraZeneca
GemcitabineLilly
GemtuzumabWyeth-Ayerst
GentamicinSchering
GlatiramerTeva
GlimepirideAventis Pharm.
Glipizide/MetforminBristol-Myers Squibb
Glyburide/MetforminBristol-Myers Squibb
GranisetronHoffman La-Roche
GriseofulvinPedinol Pharmacal, Inc.
GuanfacineShire Development, Inc.
HydrocortisoneAtlanta, Inc.
Hydrocortisone Bristol-Myers
Hydromorphone Mallinckrodt, Inc.
HydroxyureaBristol-Myers Squibb
IbuprofenMcNeil Consumer Prod
IbuprofenWhitehall-Robbins
Ibuprofen/pseudoephedrineMcNeil Consumer Prod
Ibuprofen/pseudoephedrineWhitehall-Robbins
IloperidoneNovartis
ImatinibNovartis
Imiquimod3M Pharmaceuticals
IndinavirMerck
Insulin aspart [rDNA origin]Novo Nordisk
Insulin glargineAventis
Ipilimumab Bristol-Myers Squibb Company
IrbesartanBristol-Myers Squibb
IrinotecanPharmacia & Upjohn
IsotretinoinHoffman-LaRoche, Inc.
Itraconazole

Janssen Pharmaceutica

Ivabradine

Corlanor

Ivacaftor

Vertex Pharmaceutical

Ixabepilone

Bristol-Myers Squibb Company

KetoconazoleJanssen Pharmaceutica
KetorolacAllergan
LabetalolSchering
LamivudineGlaxo Wellcome, Inc.
LamotrigineGlaxo Wellcome, Inc.
LansoprazoleTAP Holdings, Inc.
Ledipasvir the word new in a red boxGilead Sciences, Inc..
LeflunomideHoechst Marion Roussel
LenalidomideCelgene Corporation
LevalbuterolSepracor
LevetiracetamUCB Pharma
LevobetaxololAlcon
LevobunololAllergan
LevocetirizineUCB, Inc.
LevofloxacinR.W. Johnson
LevofloxacinSanten
LevomilnacipranForest Laboratories, Inc.
Levonorgestrel/ethinyl estradiolDuramed Research, Inc.
LinaclotideForest Laboratories, LLC
LinezolidPharmacia & UpJohn
LiraglutideNovo Nordisk, Inc.
LisdexamfetamineShire
LisinoprilZeneca Pharmaceuticals
LithiumRoxane
LisinoprilMerck & Co., Inc.
LomitapideAegerion
Lopinavir/RitonavirAbbott
LoratadineSchering
LorazepamWyeth-Ayerst Research
LosartanMerck
LoteprednolBausch & Lomb, Inc.
LovastatinMerck
Lurasidone Sunovion Pharmaceuticals, Inc.
MacitentanActelion Clinical Research, Inc..
MalathionTaro Pharm, USA, Inc.
MaravirocPfizer, Inc.
MeloxicamBoehringer Ingelheim
Memantine Forest Research Institute
MeropenemAstraZeneca
MesalamineProcter & Gamble
MesalamineShire
MetforminBristol-Myers Squibb
MethazolamideWyeth-Ayerst Laboratories
MethotrexateMayne Pharma (USA) Inc.
MethylphenidateMcNeil
MetipranololBausch & Lomb
MetoclopramideSchwarz
MetoprololAstraZeneca
MicafunginAstellas Pharma US, Inc.
Miconazole BioAlliance Pharma
MilnacipranCypress Bioscience, Inc.
MidazolamHoffmann-La Roche
MilrinoneSanofi Synthelabo, Inc.
MinoxidilPharmacia & UpJohn
MirabegronAstellas Pharma Global Development, Inc.
MirtazapineOrganon Inc.
ModafinilCephalon, Inc.
MoexiprilSchwarz Pharma
MometasoneSchering
Mometasone/FormoterolMerck Sharp & Dohme Corp.
MontelukastMerck & Co., Inc.
MorphineElan Drug Delivery
MorphineFaulding Pharmaceuticals
MotexafinPharmacyclics
MoxifloxacinAlcon Universal, Ltd.
NAB-paclitaxelCelgene Corporation
NabumetoneSmithKline Beecham
Naproxen/Sumatriptan Glaxo
NateglinideNovartis
NefazodoneBristol-Myers Squibb
NelfinavirAgouron Pharmaceutical
NevirapineBoehringer Ingelheim
NicardipinePDL BioPharma, Inc.
NicotineSmithKline Beecham
NilotinibNovartis Pharmaceutical
Nitric OxideINO Therapeutics
NivolumabBristol-Myers-Squibb Company
NizatidineReliant
NorfloxacinMerck
Norgestimate/ethinyl estradiolR.W. Johnson
OctreotideNovartis
OfloxacinAllergan
OlanzapineLilly
OlmesartanSankyo Pharma, Inc.
OlopatadineAlcon Research, Ltd.
OmeprazoleAstraZeneca LP
OndansetronGlaxo Wellcome
OrlistatHoffman-LaRoche
OseltamivirRoche
OxaliplatinSanofi-Synthelabo, Inc.
OxaprozinSearle
OxcarbazepineNovartis
OxybutyninAlza
OxybutyninWatson Labs
OxycodonePurdue Pharma L.P.
OxymorphoneEndo Pharm
PaliperidoneJ&J Pharm
PalonosetronHelsinn Healthcare SA
PantoprazoleWyeth-Ayerst
ParicalcitolAbbott
ParoxetineSmithKline Beecham
PeginesatideAffymax, Inc.
PegvisomantPharmacia & Upjohn
PemetrexedEli Lilly & Co.
PemirolastSanten
PimecrolimusNovartis
PioglitazoneTakeda
Polyethylene Glycol 3500

Braintree Laboratories, Inc.

Pomalidomide

Celgene Corporation

PosaconazoleSchering
Pramipexole Boehringer-Ingelheim
Prasugrel Eli Lilly & Co.
PravastatinBristol-Myers Squibb
PregabalinPfizer Global
PropofolZeneca Pharmaceuticals
QuetiapineAstraZeneca
QuinaprilParke-Davis
RabeprazoleEisai, Inc.
Raltegravir Merck & Co., Inc.
RamelteonTakeda Global Research
RamiprilKing Pharm.
RanitidineGlaxoWellcome, Inc.
RemifentanilGlaxo Wellcome, Inc.
RepaglinideNovo Nordisk
Ribavirin/Interferon alfa-2B, recombinantSchering
RifampinAventis Pharmaceuticals, Inc.
RifapentineHoechst-Marion Roussel
RifaximinSalix Pharm
Rilpivirine Janssen Prods
RisedronateProcter & Gamble
RisperidoneJanssen Research
RitonavirAbbott Laboratories
RizatriptanMerck
RocuroniumOrganon
RofecoxibMerck
RopivacaineAstraZeneca
RosiglitazoneSmithKline Beecham
RosiglitazoneS.B. Pharmco Puerto Rico, Inc.
RosuvastatinAstraZeneca Pharm LP
RufinamideEisai
SalmeterolGlaxo Wellcome, Inc.
Sapropterin BioMarin Pharmaceutical, Inc.
SaquinavirHoffman-La Roche Inc.
SertralinePfizer Pharmaceuticals
SevelamerGelTex
SevofluraneAbbott
SibutramineKnoll Pharmaceutical
SildenafilPfizer
SimvastatinMerck
SirolimusWyeth-Ayerst
SitagliptinMerck Sharp & Dohme Corp.
Sodium ferric gluconate complexWatson Laboratories
Sodium oxybateJazz Pharmaceuticals
SofosbuvirGilead Sciences, Inc.
SolifenacinAstellas Pharma Global
Somatropin [rDNA origin]Serono Laboratories
SotalolBerlex Lab., Inc.
StavudineBristol-Myers Squibb
Sugammadex  the word new in a red boxOrganon USA, Inc.
SumatriptanGlaxo Wellcome, Inc.
SunitinibC.P. Pharm c/o Pfizer, Inc.
TacrolimusR-Tech Ueno (USA)
TadalafilLilly Icos
TamoxifenAstraZeneca
TamsulosinBoehringer Ingelheim
TapentadolJanssen Research & Development, LLC
TavaboroleAnacor Pharmaceuticals, Inc.
Technetium Tc99m SestamibiBristol-Myers Squibb
TeduglutideNPS Pharmaceuticals, Inc.
Telaprevir Vertex Pharmaceuticals, Inc.
TelbivudineIdenix Pharm
TemozolomideSchering
TemsirolimusWyeth-Ayerst
TenofovirGilead Sciences
TerbinafineNovartis
TeriflunamideSanofi-Aventis U.S., Inc.
TestosteroneUnimed Pharmaceuticals
TetrabenazineBiovail Technologies
TimololMerck
TimololFalcon Pharmaceuticals
TimololSanten
Tiotropium BromideBoehringer Ingelheim
TipranavirBoehringer Ingelheim Pharm
Tizanidine Acorda Therapeutics, Inc.
TobramycinAlcon Laboratories
TobramycinFalcon Pharmaceuticals
TocilizumabHoffmann-LaRoche, Inc.
TofacitinibP.F. Prism CV
TolterodinePharmacia & Upjohn
TolvaptanOtsuka Pharmaceutical
TopiramateThe R.W. Johnson
TopotecanSmithKline Beecham
TramadolR.W. Johnson
TrametinibNovartis Pharmaceuticals Corporation
ValacyclovirGlaxoSmithKline
ValganciclovirRoche
ValsartanNovartis Pharmaceuticals
VareniclinePfizer
Velpatasvir (VEL)Gilead Sciences, Inc.
VenlafaxineWyeth-Ayerst
VerapamilElan Pharmaceuticals
Vigabatrin Lundbeck, Inc.
VilazodoneForest Labs
VinorelbineGlaxo Wellcome
VoriconazolePfizer
VortioxetineTakeda Pharms, USA
ZafirlukastZeneca Pharmaceuticals
ZanamivirGlaxo Wellcome, Inc
ZiprasidonePfizer
Zoledronic acidNovartis Pharmaceuticals
ZolmitriptanZeneca Pharmaceuticals
ZolpidemSanofi-Synthelabo Research
ZonisamideElan Pharmaceuticals

 

Page Last Updated: 11/09/2016
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