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 simply 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 This list is not updated to indicate when a Written Request has been rescinded.

MAY 2018 Approved Active Moiety (XLS - 86 KB) 

Total Approved Active Moieties Issued a Written Request = 442

Active MoietySponsorDate Issued
AbacavirGlaxo Wellcome, Inc.8/20/1998
AbataceptBristol-Myers Squibb Company9/13/2013
AcamprosateForest Labs11/9/2005
AcetaminophenCadence Pharmaceuticals8/24/2007
AcetazolamideWyeth-Ayerst10/15/1999
AdefovirGilead Sciences4/12/2002
AfatinibBoehringer Intelheim Pharmaceuticals, Inc.4/7/2017
AlbuterolDey, L.P.10/30/2001
Albuterol GlaxoSmithKline12/31/2001
AlendronateMerck Research Laboratories10/27/2000
AlfuzosinSanofi-Aventis U.S. LLC2/21/2006
AliskirenNovartis Pharmaceuticals5/13/2008
AlmotriptanPharmacia & Upjohn10/5/2001
AlogliptinTakeda Pharmaceuticals U.S.A., Inc.10/1/2013
AlosetronGlaxo Wellcome, Inc.4/7/2000
AlprazolamPharmacia & Upjohn5/21/2003
AmiodaroneWyeth Ayerst11/5/1999
AmlexanoxBlock Drug Company, Inc.3/23/2000
AmlodipinePfizer, Inc.2/4/1999
Amlodipine/BenazeprilNovartis Pharmaceuticals12/19/2001
Ammonium LactateWestwood Squibb2/22/1999
Amphetamine (mixed salts)Shire Laboratories5/6/2003
AmprenavirGlaxo Wellcome, Inc.4/7/1999
Anagrelide Shire Laboratories3/27/2003
AnastrozoleAstraZeneca Pharmaceuticals LP5/9/2001
ApixabanBristol-Myers Squibb Company3/24/2017
ApremilastCelgene Corporation5/29/2015
Aprepitant/FosaprepitantMerck & Company, Inc.2/2/2009
Argatroban Encysive Pharmaceuticals4/2/2003
AripiprazoleOtsuka Pharmaceutical Co., Ltd.2/11/2003
AsenapineOrganon USA, Inc.9/22/2009
AtazanavirBristol-Myers Squib8/2/2001
AtezolizuabGenentech, Inc.8/10/2016
AtomoxetineLilly Research Laboratories10/10/2001
AtorvastatinWarner-Lambert Export, Ltd.2/16/1999
Atovaquone/ProguanilGlaxo Wellcome, Inc.1/16/2001
AzelastineASTA Medica, Inc.4/16/1999
AzelastineMeda Pharmaceuticals, Inc.9/6/2013
Azilsartan medoxomilTakeda Pharmaceuticals U.S.A., Inc.12/6/2012
AzithromycinPfizer7/31/2003
BaclofenSchwarz Pharma, Inc.4/30/2004
BalsalazideSalix Pharmaceuticals12/17/2001
BeclomethasoneSchering Corporation6/24/1999
Beclomethasone3M Pharmaceuticals12/31/2001
BenazeprilNovartis Pharmaceuticals5/27/1999
BendamustineCephalon, Inc.1/19/2010
BesifloxacinBausch & Lomb, Inc.1/13/2011
BetamethasoneSchering Corporation7/16/1999
BetaxololLorex Pharmaceuticals2/11/1999
BetaxololAlcon Laboratories3/5/2004
BicalutamideAstraZeneca Pharmaceuticals4/17/2003
Bictegravir/Emtricitabine/Tenofovir Alafenamide(B/F/TAF) * Gilead Sciences, Inc.5/26/2017
BisoprololWyeth-Ayerst Laboratories12/23/1998
BivalirudinThe Medicines Company5/7/2007
BlinatumomabAmgen, Inc.11/12/2014
BoceprevirSchering-Plough10/14/2011
BortezomibMillenium Pharmaceuticals4/27/2010
BosutinibWyeth Pharmaceuticals, Inc.7/30/2015
BrimonidineAllergan, Inc.6/25/1999
BrinzolamideAlcon Laboratories10/15/1999
BudesonideAstraZeneca Pharmaceuticals, L.P.12/14/1998
Budesonide/FormoterolAstraZeneca Pharmaceuticals, L.P.1/28/2011
BuprenorphineReckitt Benckiser Pharmaceuticals4/12/2006
BupropionGlaxo Wellcome, Inc7/21/2000
BuspironeBristol-Myers Squibb Company10/9/1998
BusulfanOrphan Medical3/27/2000
C-UreaMeretek Diagnostics, Inc.6/10/2004
CabazitaxelSanofi-Aventis3/20/2012
CalcipotrieneLeo Pharmaceuticals2/20/2007
CalcitriolAbbott Laboratories9/17/1999
CalcitriolGalderma Laboratories10/13/2010
CanagliflozinJanssen Pharmaceuticals, Inc.3/8/2014
CandesartanAstra Pharmaceuticals3/15/1999
CapecitabineHoffmann-La Roche, Inc.3/16/2005
CarbamazepineShire Development, Inc.9/7/2005
CarboplatinBristol-Myers Squibb Company4/11/2001
CarfilzomibOnyx Therapeutics, Inc.3/17/2005
CariprazineForest Research Institute2/3/2017
CarteololCIBA Vision Corporation10/15/1999
CarvedilolSmithKline Beecham Pharmaceuticals12/23/1998
CaspofunginMerck Research Laboratories1/26/2001
CelecoxibG.D. Searle & Co.4/24/2000
CerivastatinBayer Corporation Pharmaceutical2/29/2000
CetirizinePfizer Pharmaceuticals9/3/1999
CilostazolOtsuka Pharmaceutical Co., Ltd.12/17/2001
CimetidineSmithKline Beecham 10/13/2000
CinacalcetAmgen, Inc.5/5/2010
CiprofloxacinBayer Corporation5/12/1999
CiprofloxacinAlcon Laboratories10/22/1999
CisatracuriumGlaxo Wellcome 3/17/1999
CitalopramForest Laboratories, Inc.4/28/1999
ClobazamLundbeck, LLC9/23/2013
ClofarabineILEX Products, Inc.3/7/2003
ClopidogrelSanofi-Synthelabo, Inc.10/15/2001
CobicistatGilead Sciences, Inc.3/27/2014
CobimetinibGenentech, Inc.5/27/2017
Colchicine, USPAR Holding Co., Inc.3/30/2010
Colesevelam Sankyo Pharma Development8/31/2004
ConivaptanAstellas Pharma US, Inc.6/14/2011
CrizotinibPfizer11/28/2011
Cromolyn Pharmacia & Upjohn11/24/1998
Cromolyn Bausch & Lomb Pharmaceuticals, Inc.6/25/1999
CysteamineRaptor Therapeutics, Inc.8/19/2013
CytarabineSkyePharma Inc.2/4/2000
DabrafenibNovartis Pharmaceuticals Corporation3/1/2016
DactinomycinMerck & Company, Inc.8/3/2004
DaptomycinCubist Pharmaceuticals, Inc.5/24/2013
DarbepoetinAmgen, Inc.10/2/2014
DarifenacinNovartis Pharmaceuticals Corporation7/30/2007
DarunavirTibotec, Inc.11/17/2006
DasatinibBristol-Myers Squibb Company9/17/2007
DecitabineEisai Medical Research, Inc.6/19/2009
DeferasiroxNovartis Pharmaceuticals Corporation12/17/2014
DeflazacortPTC Therapeutics, Inc.9/18/2017
DenosumabAmgen, Inc.11/30/2012
DesfluraneBaxter Healthcare Corporation12/31/2001
DesloratadineSchering Corporation6/6/2000
DesvenlafaxineWyeth Pharmaceuticals, Inc.2/10/2009
DexmedetomidineHospira, Inc.3/14/2007
DexmethylphenidateNovartis Pharmaceuticals1/3/2007
DexrazoxanePfizer Pharmaceuticals6/17/2004
DichlorphenamideMerck Research Laboratories10/15/1999
DiclofenacNovartis Consumer Health, Inc.4/30/2009
DiclofenacXanodyne Pharmaceuticals, Inc.2/22/2011
DidanosineBristol-Myers Squibb Company8/5/1999
DifluprednateSirion Therapeutics, Inc.2/18/2009
DivalproexAbbott Laboratories1/31/2006
Divalproex(valproate)Abbott Laboratories8/9/2002
DocetaxelSanofi-Aventis, U.S., Inc.6/11/2007
DolutegravirViiV Healthcare3/3/2010
DorzolamideMerck Research Laboratories6/24/1999
DulaglutideEli Lilly and Company8/31/2016
DuloxetineEli Lilly & Co.6/23/2006
EfavirenzDuPont Pharmaceuticals Company9/17/1998
EfinaconazoleDow Pharmaceutical Sciences4/17/2015
EletriptanPfizer, Inc.7/14/2004
EltrombopagGlaxoSmithKline1/25/2010
ElvitegravirGilead Sciences, Inc.2/9/2015
EmtricitabineTriangle Pharmaceuticals, Inc.7/16/1999
Enalapril Merck Research Laboratories10/24/1998
EnfuvirtideHoffman-La Roche, Inc.1/9/2001
EnoxaparinAventis Pharmaceuticals, Inc.3/7/2003
EntecavirBristol-Myers Squibb Company11/28/2006
EribulinEisai, Inc.7/8/2016
EpirubicinPharmacia & Upjohn2/19/2002
EplerenoneG.D. Searle and Company8/17/2000
ErlotinibOSI Pharmaceuticals, Inc.11/27/2000
ErtapenemMerck & Co., Inc.5/15/2000
EslicarbazepineSunovion Pharmaceutical, Inc.7/8/2016
EsmololBaxter Pharmaceuticals Products, Inc.9/30/1999
EsomeprazoleAstraZeneca Pharmaceuticals, LP12/31/2001
EszopicloneSepracor, Inc.8/2/2006
EtodolacWyeth-Ayerst Research2/3/1999
EtravirineTibotec, Inc.4/3/2008
EverolimusNovartis Pharmaceuticals Corporation4/25/2000
ExenatideAmylin Pharmaceuticals, Inc.3/29/2006
EzetimibeMSP Singapore Co., LLC4/15/2004
FamciclovirNovartis Pharmaceuticals Corporation9/10/2001
FamotidineMerck & Company, Inc.8/3/1999
FelodipineAstra Pharmaceuticals, L.P.12/31/1998
FenoldopamElan Pharmaceuticals4/14/1999
FentanylAnesta Corporation12/23/2003
FentanylJanssen Pharmaceuticals7/15/1999
Ferric CitrateKeryx Biopharmaceuticals, Inc.5/29/2015
FesoterodinePfizer, Inc.11/14/2011
FexofenadineAventis Pharmaceuticals3/17/2000
FingolimodNovartis Pharmaceutical Corporation3/20/2013
FluconazolePfizer Pharmaceuticals Group12/31/2001
FludarabineBerlex Laboratories11/9/2001
FluocinoloneBausch & Lomb Pharmaceuticals, Inc.4/12/2001
FluoxetineEli Lilly and Company4/12/1999
FluticasoneGlaxo Wellcome, Inc.6/25/1999
FluvastatinNovartis Pharmaceuticals Corporation12/4/2001
FluvoxamineSolvay Pharmaceuticals11/30/1999
Formoterol Novartis Pharmaceuticals Corporation12/31/2001
FosamprenavirGlaxoSmithKline12/26/2001
FosaprepitantMerck2/2/2009
FosinoprilBristol-Myers Squibb Company2/3/1999
FosphenytoinPfizer, Inc.12/17/1998
FospropofolEisai, Inc.1/13/2012
FulvestrantAstraZeneca Pharmaceuticals, LP10/21/2002
GabapentinParke-Davis Pharmaceutical Research10/9/1998
GadopentetateBayer HealthCare Pharmaceuticals, Inc.1/26/2009
GatifloxacinBristol-Myers Squibb Company5/18/2001
GatifloxacinAllergan, Inc.10/4/2001
GefitinibAstraZeneca, Pharmaceuticals, LP12/4/2000
GemcitabineLilly Research Laboratories1/9/2001
GemtuzumabWyeth-Ayerst Research Laboratories 1/10/2001
GentamicinSchering Corporation11/1/1999
GlatiramerTEVA Pharmaceuticals USA1/3/2000
Glecaprevir/PibrentasvirAbbVie, Inc.2/3/2017
GlimepirideAventis Pharmaceuticals12/31/2001
Glipizide/MetforminBristol-Myers Squibb Company6/18/2002
Glyburide/MetforminBristol-Myers Squibb Company1/31/2001
Granisetron Hoffman La-Roche, Inc.12/19/2002
GriseofulvinPedinol Pharmacal, Inc.9/30/2005
GuanfacineShire Development, Inc.10/30/2009
Halobetasol Propionate NEW Sun Pharmaceutical Industries, Inc. 11/29/2017
HydrocortisoneAtlanta, Inc.12/12/2003
Hydrocortisone Bristol-Myers Squibb Company  10/14/2005
HydromorphoneMallinckrodt, Inc.3/15/2011
HydroxyureaBristol-Myers Squibb Company3/22/2002
IbuprofenMcNeil Consumer Products Company6/8/1998
IbuprofenWhitehall-Robbins6/8/1998
Ibuprofen/pseudoephedrineMcNeil Consumer Products Company9/7/1999
Ibuprofen/pseudoephedrineWhitehall-Robbins Healthcare5/30/2000
IloperidoneNovartis Pharmaceuticals Corporation5/13/2010
ImatinibNovartis Pharmaceuticals Corporation9/12/2000
Imiquimod3M Pharmaceuticals12/28/2001
IndinavirMerck Research Laboratories6/25/1999
Insulin aspart [rDNA origin]Novo Nordisk Pharmaceuticals, Inc.12/14/1999
Insulin glargineAventis Pharmaceutical, Inc.12/23/1998
IpilimumabBristol-Myers Squibb Company7/7/2014
IrbesartanBristol-Myers Squibb Company12/23/1998
IrinotecanPharmacia & Upjohn1/22/2001
IsavuconazoniumAstellas Pharma US, Inc.10/24/2017
IsotretinoinHoffman-LaRoche, Inc.6/22/2009
ItraconazoleJanssen Pharmaceutica Research2/9/1999
IvabradineCorlanor4/4/2015
IvacaftorVertex Pharmaceutical3/14/2016
IxabepiloneBristol-Myers Squibb Company6/22/2007
KetoconazoleJanssen Pharmaceutica Research4/26/1999
KetorolacAllergan, Inc.5/10/2000
LabetalolSchering Corporation12/23/1998
LamivudineGlaxo Wellcome, Inc.11/25/1998
LamotrigineGlaxo Wellcome, Inc.12/17/1998
LansoprazoleTAP Holdings, Inc.8/26/1999
LedipasvirGilead Sciences, Inc.9/2/2016
LeflunomideHoechst Marion Roussel, Inc.3/30/1999
LenalidomideCelgene Corporation9/13/2014
LevalbuterolSepracor, Inc.3/14/2000
LevetiracetamUCB Pharma, Inc.8/21/2001
LevobetaxololAlcon Laboratories, Inc.10/15/1999
LevobunololAllergan, Inc.10/15/1999
LevocetirizineUCB, Inc.2/3/2009
LevofloxacinR.W. Johnson10/22/1999
LevofloxacinSanten, Inc.12/20/2001
LevomilnacipranForest Laboratories, Inc.9/5/2014
Levonorgestrel/ethinyl estradiolDuramed Research, Inc.8/14/2005
LinaclotideForest Laboratories, LLC3/11/2016
LinezolidPharmacia & UpJohn12/22/1999
LiraglutideNovo Nordisk, Inc.9/13/2012
LisdexamfetamineShire6/3/2014
LisinoprilZeneca Pharmaceuticals12/23/1998
LisinoprilMerck & Co., Inc.12/23/1998
LithiumRoxane9/26/2003
LomitapideAegerion1/20/2015
Lopinavir/RitonavirAbbott Laboratories3/31/1999
LoratadineSchering Corporation10/15/1998
LorazepamWyeth-Ayerst Research7/5/2002
LorcaserinEisai, Inc.10/24/2017
LosartanMerck Research Laboratories7/1/1999
LoteprednolBausch & Lomb, Inc.4/26/2013
LovastatinMerck & Co., Inc.2/3/1999
LurasidoneSunovion Pharmaceuticals, Inc.4/20/2012
MacitentanActelion Clinical Res., Inc.4/13/2016
MalathionTaro Pharm, USA, Inc.4/13/2016
MaravirocPfizer, Inc.11/28/2006
MeloxicamBoehringer Ingelheim Pharmaceuticals11/22/2004
MemantineForest Research Institute1/25/2012
MeropenemAstraZeneca9/10/2004
MesalamineProcter & Gamble Pharmaceuticals, Inc.11/30/2001
MesalamineShire5/2/2014
MetforminBristol-Myers Squibb Company6/9/1999
MethazolamideWyeth-Ayerst Laboratories 10/15/1999
MethotrexateMayne Pharma (USA) Inc.7/20/2006
MethylphenidateMcNeil Consumer & Specialty Pharm.6/25/2003
MetipranololBausch & Lomb10/15/1999
MetoclopramideSchwarz Pharma, Inc.7/20/2005
MetoprololAstraZeneca, Pharmaceuticals, LP10/19/1999
MicafunginAstellas Pharma US, Inc.5/23/2007
MiconazoleBioAlliance Pharma3/8/2012
MidazolamHoffmann-La Roche, Inc.7/20/1998
MilnacipranCypress Bioscience, Inc.2/2/2009
MilrinoneSanofi Synthelabo, Inc.1/21/2000
MinoxidilPharmacia & Upjohn Company11/8/2000
MirabegronAstellas Pharma Global Development, Inc.3/18/2016
MirtazapineOrganon, Inc.4/28/1999
ModafinilCephalon, Inc.6/17/2004
MoexiprilSchwarz Pharmaceuticals3/15/1999
MometasoneSchering Corporation3/17/1999
Mometasone/FormoterolMerck Sharp & Dohme Corp.7/23/2012
MontelukastMerck & Co., Inc.3/4/1999
MorphineElan Drug Delivery3/28/2003
MorphineFaulding Pharmaceuticals3/28/2003
MotexafinPharmacyclics12/27/2001
MoxifloxacinAlcon Universal, Ltd.6/26/2000
NAB-paclitaxelCelgene Corporation10/29/2014
NabumetoneSmithKline Beecham3/19/1999
NateglinideNovartis Pharmaceuticals12/31/2001
NefazodoneBristol-Myers Squibb Company4/28/1999
NelfinavirAgouron Pharmaceuticals, Inc.3/29/1999
NevirapineBoehringer Ingelheim Pharmaceuticals9/11/1998
NicardipinePDL BioPharma, Inc.9/18/2007
NicotineSmithKline Beecham12/4/1998
NilotinibNovartis Pharmaceuticals 6/19/2009
Nitric OxideINO Therapeutics4/30/2010
NivolumabBristol-Myers Squibb Company9/11/2014
NizatidineReliant Pharmaceuticals6/22/2001
NorfloxacinMerck & Co., Inc.11/1/1999
Norgestimate/ethinyl estradiolR.W. Johnson Pharmaceutical Research11/12/2002
OctreotideNovartis Pharmaceuticals Corporation1/7/2004
OfloxacinAllergan, Inc.10/22/1999
OlanzapineLilly Research Laboratories11/30/2001
OlmesartanSankyo Pharma, Inc.3/6/2001
OlopatadineAlcon Research, Ltd.7/19/2007
OmeprazoleAstraZeneca Pharmaceuticals, LP7/1/1999
OndansetronGlaxo Wellcome, Inc.6/26/2001
OrlistatHoffman-La Roche, Inc.8/9/2000
OseltamivirHoffman-La Roche, Inc.3/1/2000
OxaliplatinSanofi-Synthelabo, Inc.12/19/2004
OxaprozinSearle2/3/1999
OxcarbazepineNovartis Pharmaceuticals Corporation2/28/2000
OxybutyninAlza Corporation11/30/2000
OxybutyninWatson Laboratories, Inc.5/14/2004
OxycodonePurdue Pharma L.P.11/4/1998
OxymorphoneEndo Pharmaceuticals3/16/2007
PaliperidoneJ&J Pharmaceuticals11/2/2006
PalonosetronHelsinn Healthcare SA7/23/2010
PantoprazoleWyeth-Ayerst Laboratories12/31/2001
ParicalcitolAbbott Laboratories2/22/2001
ParoxetineSmithKline Beecham Pharmaceuticals4/28/1999
PeginesatideAffymax, Inc.1/4/2013
PegvisomantPharmacia & Upjohn Co.5/23/2003
PemetrexedEli Lilly & Company10/5/2001
PemirolastSanten, Inc.2/18/1999
PimecrolimusNovartis Pharmaceutical Corporation9/27/1999
PioglitazoneTakeda Pharmaceuticals, Inc.4/3/2002
PitavastatinKowa Research Institute, Inc.11/2/2016
PlerixaforGenzyme6/29/2015
Polyethylene Glycol 3350Braintree Laboratories, Inc.12/27/2001
PomalidomideCelgene Corporation11/20/2015
PosaconazoleSchering Corporation2/28/2008
PramipexoleBoehringer-Ingelheim2/13/2009
PrasugrelEli Lilly & Co.12/19/2012
PravastatinBristol-Myers Squibb8/4/1999
PregabalinPfizer Global6/8/2005
PropofolZeneca Pharmaceuticals4/2/1999
QuetiapineAstraZeneca Pharmaceuticals, LP2/11/2003
QuinaprilParke-Davis Pharmaceutical Research12/23/1998
RabeprazoleEisai, Inc.12/31/2001
RaltegravirMerck & Co., Inc.8/18/2006
RamelteonTakeda Global Research6/2/2011
RamiprilKing Pharmaceuticals12/19/2001
RanitidineGlaxoWellcome, Inc. 8/26/1998
RemifentanilGlaxo Wellcome, Inc.12/17/1998
RepaglinideNovo Nordisk2/1/2000
Ribavirin/Interferon alfa-2B, recombinantSchering-Plough Research Institute1/25/1999
RifampinAventis Pharmaceuticals, Inc.9/30/2003
RifapentineHoechst Marion Roussel, Inc.6/19/1998
RifaximinSalix Pharmaceuticals, Inc.4/15/2003
RilpivirineJanssen Prods7/30/2008
RisedronateProcter & Gamble Pharmaceuticals4/19/2002
RisperidoneJanssen Research Foundation11/25/2002
RitonavirAbbott Laboratories4/16/1999
RivaroxabanJanssen Research & Development, LLC6/8/2017
RizatriptanMerck Research Laboratories3/6/2009
RocuroniumOrganon, Inc.12/31/2001
RofecoxibMerck & Co., Inc.5/7/2001
RopivacaineAstraZeneca Pharmaceuticals, LP3/2/2000
RosiglitazoneSmithKline Beecham Pharmaceuticals2/1/2000
RosiglitazoneS.B. Pharmco Puerto Rico, Inc.12/15/2003
RosuvastatinAstraZeneca Pharmaceuticals, LP3/7/2006
RufinamideEisai, Inc.6/21/2000
RuxolitinibJakafinda12/11/2015
Sacubitril/ValsartanNovartis Pharmaceuticals Corp.3/2/2017
SalmeterolGlaxo Wellcome, Inc.5/20/1999
SapropterinBioMarin Pharmaceutical, Inc.1/14/2008
SaquinavirHoffman-La Roche Inc.4/9/1999
SertralinePfizer Pharmaceuticals4/28/1999
SevelamerGelTex Pharmaceuticals, Inc.1/15/2002
SevofluraneAbbott Laboratories3/2/2000
SibutramineKnoll Pharmaceuticals6/1/1999
SildenafilPfizer, Inc.12/17/2001
SimvastatinMerck & Co., Inc.8/31/1999
SirolimusWyeth-Ayerst Research9/15/1999
SitagliptinMerck Sharp & Dohme Corp.11/16/2012
Sodium ferric gluconate complexWatson Laboratories, Inc.8/9/2002
Sodium Nitroprusside NEW Abbott Laboratories7/8/2002
Sodium oxybateJazz Pharmaceuticals3/10/2014
SofosbuvirGilead Sciences, Inc.9/2/2016
SolifenacinAstellas Pharma Global7/27/2012
Somatropin [rDNA origin]Serono Laboratories6/28/2000
SotalolBerlex Laboratories, Inc.1/15/1999
StavudineBristol-Myers Squibb8/20/1999
SugammadexOrganon USA, Inc.10/28/2016
SumatriptanGlaxo Wellcome, Inc.4/24/2014
Sumatriptan/naproxenPozen, Inc.6/29/2007
SunitinibC.P. Pharmaceuticals Intl c/o Pfizer, Inc.10/23/2006
TacrolimusR-Tech Ueno (USA), Inc.4/19/2000
TadalafilEli Lilly and Company11/6/2006
TamoxifenAstraZeneca Pharmaceuticals4/5/2000
TamsulosinBoehringer Ingelheim Pharmaceuticals1/10/2006
TapentadolJanssen Research & Development, LLC7/8/2013
TavaboroleAnacor Pharmaceuticals, Inc.4/17/2015
Tbo-filgrastinTeva Branded Pharmaceutical Products R&D, Inc.9/21/2017
Technetium Tc99m SestamibiBristol-Myers Squibb Medical Imaging12/17/2004
TeduglutideNPS Pharmaceuticals, Inc.6/12/2015
TelaprevirVertex Pharmaceuticals, Inc.10/7/2011
TelbivudineIdenix Pharmaceuticals Inc.12/1/2006
TemozolomideSchering Corporation1/9/2001
TemsirolimusWyeth-Ayerst Research Laboratories 1/12/2001
TenofovirGilead Sciences, Inc.12/21/2001
TerbinafineNovartis Pharmaceuticals Corporation2/28/2001
TeriflunamideSanofi-Aventis U.S., Inc.3/7/2013
TestosteroneUnimed Pharmaceuticals, Inc.6/21/2002
TetrabenazineBiovail Technologies, Ltd.7/30/2010
TimololMerck Research Laboratories7/6/1999
TimololFalcon Pharmaceuticals10/15/1999
TimololSanten Incorporated10/15/1999
Tiotropium BromideBoehringer Ingelheim2/12/2016
TipranavirBoehringer Ingelheim Pharmaceuticals1/22/2003
TizanidineAcorda Therapeutics, Inc.12/20/2012
TobramycinAlcon Laboratories10/22/1999
TobramycinFalcon Pharmaceuticals10/22/1999
TocilizumabHoffmann-LaRoche, Inc.11/15/2012
TofacitinibP.F. Prism CV8/12/2015
TolterodinePharmacia & Upjohn Company1/23/2001
TolvaptanOtsuka Pharmaceutical Company, Ltd.6/15/2011
TopiramateThe R.W. Johnson7/9/2004
TopotecanSmithKline Beecham5/16/2000
TramadolR.W. Johnson3/30/1999
TrametinibNovartis Pharmaceuticals Corporation3/1/2016
ValacyclovirGlaxoSmithKline8/2/2001
ValganciclovirRoche Pharmaceuticals6/20/2001
ValsartanNovartis Pharmaceuticals12/19/2000
VareniclinePfizer, Inc.6/12/2007
Velpatasvir(VEL)Gilead Sciences, Inc.9/2/2016
VenlafaxineWyeth-Ayerst Laboratories 4/28/1999
VerapamilElan Pharmaceutical Research Corp.2/3/1999
VigabatrinLundbeck, Inc.8/25/2011
VilazodoneForest Labs11/20/2012
VinorelbineGlaxo Wellcome, Inc.1/9/2001
VoriconazolePfizer Global Research & Development12/21/2001
VortioxetineTakeda Pharms, USA9/24/2015
ZafirlukastZeneca Pharmaceuticals1/4/1999
ZanamivirGlaxo Wellcome, Inc12/29/1998
ZiprasidonePfizer, Inc.2/11/2003
Zoledronic acidNovartis Pharmaceuticals Corporation8/19/2002
ZolmitriptanZeneca Pharmaceuticals3/26/1999
ZolpidemSanofi-Synthelabo Research12/27/2005
ZonisamideElan Pharmaceuticals, Inc.5/21/2001
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