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Report of FDA Approved Commercial Products Involving NIH Extramural Support

Items listed on this page have been identified as having involved NIH extramural support that helped to further the research and development of these final products. Although each product may have multiple funding sources and may include multiple technologies, the products are listed because NIH extramural support was also identified as being involved.

Please note that the time for development of a successful FDA approved drug, from basic research and initial identification of a potential candidate compound through to FDA approval, can range from 5 years to 15 years.

Commercial NameFDA Approval TypeFDA Approval NumberNIH Support
AccuroMedical DeviceK132736R43 EB015232
Active Contact SystemMedical DeviceB102116HD036154
AldurazymeBiologic125058AI013526
AmnioGraftBiologicHCT/PR01 EY006819
AtheNA Multi-Lyte Borrelia VlsE-1 IgG/pepC10 IgM Plus Test SystemMedical DeviceK100728R43 AI069564
Medical Devicek100728R43 AI069564
k100728R43 AI069564
BexxarDrugBL 125011/0CA042768
DrugBL 125011/0CA056794
Biofiber ScaffoldMedical DeviceK102788R43 GM064863
BisBlock (TM)DE006427
BreastViewMedical DeviceK010514CA059175
Medical DeviceK010514CA065246
Medical DeviceK010514CA069175
Clinscan 300Medical DeviceHL060802
EmtrivaDrug021500AI026055
Drug021500AI028731
Drug021896AI026055
Drug021896AI028731
Emtriva (CAPSULE; ORAL 200MG)Drug021500AI026055
Drug021500AI028731
Emtriva (SOLUTION; ORAL 10MG/ML)Drug021896AI026055
Drug021896AI028731
EnbrelBiologicBLA103795/5359AI013526
EndoWave Peripheral Infusion SystemMedical DeviceKO72507R44 HL057739
EpzicomDrug021652AI026055
Drug021652AI028731
ERBITUXDrugNDC66733-948-23CA009290
DrugNDC66733-948-23CA023052
DrugNDC66733-948-23CA033397
DrugNDC66733-948-23GM017702
EstrametCA022795
Fel-O-Vax FIVAI030904
FilmArray Blood Culture Identification PanelMedical DeviceK130914R43 AI063695
Medical DeviceK130914U01 AI061611
Medical DeviceK143171AI082184
FilmArray Gastrointestinal PanelMedical DeviceK140407R43 AI063695
Medical DeviceK140407U01 AI061611
FilmArray Respiratory PanelMedical DeviceK110764R43 AI063695
Medical DeviceK110764U01 AI061611
Medical DeviceK123620R43 AI063695
Medical DeviceK123620U01 AI061611
FilmArray Respiratory Panel v1.6Medical DeviceK120267R43 AI063695
Medical DeviceK120267U01 AI061611
FilmArray SystemMedical DeviceK103175R43 AI063695
Medical DeviceK103175U01 AI061611
Flu MistBiologicBL 125020/43AI005053
BiologicBL 125020/43AI020591
BiologicBL 125020/43AI021765
BiologicBL 125020/43AI052564
BiologicBL 125020/43AI072521
BiologicBL 125020/43CA021765
BiologicBL 125020/43RR004154
FluMistBiologic125020AI005053
Biologic125020AI020591
Biologic125020AI021765
Biologic125020AI052564
Biologic125020AI072521
Biologic125020CA021765
Biologic125020RR004154
BiologicBL 125020/43AI005053
BiologicBL 125020/43AI020591
BiologicBL 125020/43AI021765
BiologicBL 125020/43AI052564
BiologicBL 125020/43AI072521
BiologicBL 125020/43CA021765
BiologicBL 125020/43RR004154
GalaFLEX MeshMedical DeviceK140533R43 GM064863
GEM 21SMedical DeviceP040013DE007010
GEMS 21Medical DeviceP040013DE007010
HVT 100Medical Devicek010253DK055444
Hylenex RecombinantDrug021859AI013526
Image CheckerK023003CA089452
Image Checker CT WorkstationMedical DeviceK023003CA062625
Medical DeviceK023003CA064370
ImageCheckerMedical DeviceK023003AR042739
Medical DeviceK023003CA009649
Medical DeviceK023003CA024806
Medical DeviceK023003CA041851
Medical DeviceK023003CA044926
Medical DeviceK023003CA047043
Medical DeviceK023003CA048985
Medical DeviceK023003CA052101
Medical DeviceK023003CA060187
Medical DeviceK023003CA062625
Medical DeviceK023003CA064370
Medical DeviceK023003CA089452
Medical DeviceK023003HL036238
Medical DeviceK023003NS030400
Medical DeviceP030012AR042739
Medical DeviceP030012CA009649
Medical DeviceP030012CA024806
Medical DeviceP030012CA047043
Medical DeviceP030012CA048985
Medical DeviceP030012CA062625
Medical DeviceP030012CA064370
Medical DeviceP030012CA066132
Medical DeviceP030012CA079711
Medical DeviceP030012CA089452
Medical DeviceP030012CA095279
Medical DeviceP030012DK020595
Medical DeviceP030012DK042086
Medical DeviceP030012MH045533
Medical DeviceP030012MH048518
Medical DeviceP030012RR011459
Imagechecker CAD System for MammographyMedical Devicep970058AR042739
Medical DeviceP970058AR042739
Medical DeviceP970058CA009649
Medical DeviceP970058CA024806
Medical DeviceP970058CA041851
Medical DeviceP970058CA047043
Medical DeviceP970058CA048985
Medical Devicep970058CA048985
Medical DeviceP970058CA060187
Medical DeviceP970058CA062625
Medical DeviceP970058CA064370
Medical DeviceP970058CA066132
Medical DeviceP970058CA079711
Medical DeviceP970058CA089452
Medical DeviceP970058HL052567
Medical DeviceP970058RR011459
IntraLase FS LaserMedical DeviceK002890CA042947
LAVA XVMedical DeviceHL060802
LinasysMedical DeviceK071063CA091352
Medical DeviceK071063CA115263
Medical DeviceK071063DK009671
Medical DeviceK071063EB007694
Medical DeviceK071063GM052798
LMS-Lung/TrackMedical DeviceK070868CA095279
LyricaDrug021446NS015703
MenostarDrugNDA# 021674AG005407
MeVis Visia CT Lung (formerly Imagechecker CT)Medical DeviceK023003CA024806
Medical DeviceK023003CA047043
Medical DeviceK023003CA048985
Medical DeviceK023003CA062625
MeVis Visia CT Lung System (fna Imagechecker CT)Medical DeviceK023003CA024806
Medical DeviceK023003CA044926
MeVis Visia CT Lung System (formerly ImageChecker CT)Medical DeviceK023003CA024806
MeVis Visia CT Lung System (formerly Imagechecker CT)Medical DeviceK023003CA024806
Medical DeviceK023003CA044926
MeVis Visia CT Lung System (formerly ImageChecker CT)Medical DeviceK023003CA047043
MeVis Visia CT Lung System (formerly Imagechecker CT)Medical DeviceK023003CA047043
Medical DeviceK023003CA048985
Medical DeviceK023003CA052101
Medical DeviceK023003CA062625
Medical DeviceK023003NS030400
MonoMaxMedical DeviceK100876R44 GM064863
OnGuardMedical DeviceP000041CA024806
Medical DeviceP000041CA047043
Medical DeviceP000041CA048985
Medical DeviceP000041CA060187
Medical DeviceP000041CA062625
Medical DeviceP000041CA064370
Medical DeviceP000041CA089452
Medical DeviceP000041HL052567
ONTAKBiologic1258AI012500
Biologic1258AM016684
OrenciaDrug125118AI013526
PhasixMedical DeviceK120728R43 GM064863
Phasix MeshMedical DeviceK161424R43 GM064863
Phasix ST MeshMedical DeviceK143380R43 GM064863
PlenaxisHD033172
ProKeraMedical DeviceK032104R01 EY006819
ProKera (TM)Medical DeviceK032104R01 EY006819
ProKera (TM) Ophthalmic ConformerR01 EY006819
ProleukinBiologicBLA103293AI018321
BiologicBLA103293CA008748
BiologicBLA103293CA020194
BiologicBLA103293CA021525
BiologicBLA103293CA022507
BiologicBLA103293CA023766
BiologicBLA103293CA025608
BiologicBLA103293CA031525
BiologicBLA103293CA033050
DrugBLA103293AI018321
DrugBLA103293CA008748
DrugBLA103293CA020194
DrugBLA103293CA021525
DrugBLA103293CA022507
DrugBLA103293CA023766
DrugBLA103293CA025608
DrugBLA103293CA031525
DrugBLA103293CA033050
Rapid ScreenMedical DeviceP000041CA024806
Medical DeviceP000041CA060187
Medical DeviceP000041CA062625
Medical DeviceP000041CA064370
P000041CA062625
RapidScreenMedical DeviceP000041CA024806
Medical DeviceP000041CA047043
Medical DeviceP000041CA048985
Medical DeviceP000041CA060187
Medical DeviceP000041CA062625
Medical DeviceP000041CA064370
Medical DeviceP000041RR011459
RelistorDrugNDA021964GM022220
DrugNDA021964NS012324
DrugNDA021964RR000055
RestasisDrug50-790EY005720
RETevalMedical DeviceK142567EY021121
RF ARRMedical DeviceHL060802
Spinraza nusinersenDrugNDA209531NS040275
THYRETAIN TM TSI REPORTER BIOASSAYMedical DeviceK092229AI007194
ThyrogenDrugNDA020898CA023185
TrusoptEY002227
Trusopt & CosoptEY002227
TruvadaDrug021752AI026055
Drug021752AI028731
TubeClearMedical DeviceK131052HD065365
TysabriBiologic125104AI013526
UDP-Glycuronosyl Transferase 1A 1TA Repeat Genotype, UGT1A1Medical DeviceK051824CA014599
Medical DeviceK051824CM007301
Medical DeviceK051824GM061393
UDP-Glycuronosyl Transferase 1A1 TA Repeat Genotype, UGT1A1Medical DeviceK051824CA014599
Medical DeviceK051824CM007301
Medical DeviceK051824GM061393
VectibixBiologicBLA125147/0AI013526
Vibrant XVMedical DeviceHL060802
xCAT ENTMedical DeviceK061834R44 CA107895
Xtandi (enzalutamide)Drug203415CA092131
YervoyBiologicBLA 125377CA009179
BiologicBLA 125377CA040041
ZeritDrugCA028852
ZolinzaDrugNDA 21-991CA057227


Commercial NameSupport
Acthrel
AltoprevNS033325
AtriplaAI026055
AvonexGM025821
Calcijex
CardioliteCA034970 et al
CeprotinHL030340
CeretecCA033526
CetrotideCA040003
CialisNCI (No specific award identified)
Clolar
CombivirNIH 021935 (No Institute Identified)
CosoptEY002227
Epivir/Epivir HBCNIH 021935 (No Institute Identified)
Epogen
EpzicomCA023263
ErbituxCA00929, CA02305, CA03339, GM01770
ExosurfHL024075
FabrazymeDK034045
FuzeonAI030411
GaniteAM026741
GerefAM026741
GkuadekGM026698
GlidialGM026698
HabitrolRR05756 et al
HumatropeCA014026 et al
HumiraHD021989, HD016580
INOmaxHD016580, HD02198
KaletraAI027220
Macugen
MenostarAG05407
Miraluma
NamendaEY006087
NeulastaCA032516, HL031780, CA020194, CA023766 and CA000966
NeupogenCA032516, HL031780, CA020194, CA023766 and CA000966
NorvirAI027220
ONTAKAI012500, AM016684
OraceaDE003987, et. al.
Procrit
ProleukinCA008748, et. al.
RelgenAM026741
RelistorRR00055
Seri MeshAR046563, AR049139, DE013405, DE014622
SolirisHL036061 and GM040924.
Somatuline DepotAM018370
Taxol
ThyrogenCA023185
TrelstarCA040003 and CA040004
TrizivirCA023263
TrusoptEY002227
TruvadaAI026055, et. al.
TysabriCA049259
XalatanEY000333
XigrisHL030340, GM037704, et. al.
ZemplarDK014881
ZeritCA028852
ZiagenCA023263

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