All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2020

FDA approved the original submission of 129 new drug and biologics license applications in 2020, from 108 sponsors. FDA marks 15 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
GEMTESAvibegronSUMITOMO PHARMA AMNDA213006
EBANGAansuvimab-zyklRIDGEBACK BIOTHERAPEUTICSBLA761172
ORGOVYXrelugolixSUMITOMO PHARMA AMNDA214621
RIABNIrituximab-arrxAMGEN INCBLA761140
MARGENZAmargetuximab-cmkbMACROGENICS INCBLA761150
KLISYRItirbanibulinALMIRALLNDA213189
ORLADEYOberotralstat dihydrochlorideBIOCRYSTNDA214094
GALLIUM GA 68 GOZETOTIDEgallium ga-68 gozetotideUNIV CA LOS ANGELESNDA212642
GALLIUM GA 68 GOZETOTIDEgallium ga-68 gozetotideUNIV OF CA SAN FRANNDA212643
GAVRETOpralsetinibBLUEPRINT MEDICINESNDA214701
HETLIOZ LQtasimelteonVANDA PHARMS INCNDA214517
THYQUIDITYlevothyroxine sodiumSTEVENS JNDA214047
DANYELZAnaxitamab-gqgkY-MABS THERAPEUTICS INCBLA761171
IMCIVREEsetmelanotide acetateRHYTHMNDA213793
OXLUMOlumasiran sodiumALNYLAM PHARMS INCNDA214103
XOFLUZAbaloxavir marboxilGENENTECH INCNDA214410
ZOKINVYlonafarnibSENTYNL THERAPS INCNDA213969
SUTABmagnesium sulfate, potassium chloride, sodium sulfateAZURITYNDA213135
LABETALOL HYDROCHLORIDElabetalol hydrochlorideHIKMANDA213330
SESQUIENTfosphenytoin sodiumLUPINNDA210864
BRONCHITOLmannitolPHARMAXIS EUROPENDA202049
EYSUVISloteprednol etabonateALCON LABS INCNDA210933
VEKLURYremdesivirGILEAD SCIENCES INCNDA214787
ESOMEPRAZOLE MAGNESIUMesomeprazole magnesiumDEXCELNDA214278
EPHEDRINE SULFATEephedrine sulfatePH HEALTHNDA213994
INMAZEBatoltivimab, odesivimab, maftivimabREGENERON PHARMACEUTICALSBLA761169
ALKINDI SPRINKLEhydrocortisoneETONNDA213876
ATROPINE SULFATEatropine sulfateACCORD HLTHCARENDA214652
XELJANZtofacitinib citratePFIZERNDA213082
GAVRETOpralsetinibRIGEL PHARMSNDA213721
DETECTNETcopper cu-64 dotatateCURIUMNDA213227
ONUREGazacitidineBRISTOLNDA214120
QDOLOtramadol hydrochlorideROSEMOUNTNDA214044
SOGROYAsomapacitan-becoNOVO NORDISK INCBLA761156
XARACOLLbupivacaine hydrochlorideINNOCOLL PHARMSNDA209511
WINLEVIclascoteroneSUN PHARMNDA213433
METHOTREXATEmethotrexateACCORD HLTHCARENDA214121
PEMETREXEDpemetrexedACTAVISNDA208419
CYSTADROPScysteamine hydrochlorideRECORDATI RARENDA211302
ENSPRYNGsatralizumabGENENTECHBLA761149
VILTEPSOviltolarsenNIPPON SHINYAKUNDA212154
EVRYSDIrisdiplamGENENTECH INCNDA213535
OLINVYKoliceridineTREVENANDA210730
LAMPITnifurtimoxBAYER HEALTHCARENDA213464
XTANDIenzalutamideASTELLASNDA213674
VASOPRESSINvasopressinAM REGENTNDA212593
MONJUVItafasitamab-cxixMORPHOSYS US INCBLA761163
CYCLOPHOSPHAMIDEcyclophosphamideDR REDDYSNDA212501
XEGLYZEabametapirLNHCNDA206966
BREZTRI AEROSPHEREbudesonide, formoterol fumarate, glycopyrrolateASTRAZENECA ABNDA212122
XYWAVcalcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybateJAZZNDA212690
WYNZORAbetamethasone dipropionate, calcipotrieneMC2NDA213422
CARBON DIOXIDE, USPcarbon dioideNEXAIR LLCNDA215007
UPNEEQoxymetazoline hydrochlorideRVL PHARMSNDA212520
INQOVIcedazuridine, decitabineTAIHO ONCOLOGYNDA212576
HULIOadalimumab-fkjpMYLAN PHARMS INCBLA761154
QWOcollagenase clostridium histolyticum-aaesENDO GLOBAL AESTHETICS LTDBLA761146
BYFAVOremimazolam besylateACACIANDA212295
MULTRYScupric sulfate, manganese sulfate, selenious acid, zinc sulfateAM REGENTNDA209376
RUKOBIAfostemsavir tromethamineVIIV HLTHCARENDA212950
DOJOLVItriheptanoinULTRAGENYX PHARM INCNDA213687
Nitrogen, NFnitrogenAIR LIQUIDE CANADA INCNDA214858
PHESGOpertuzumab, trastuzumab, and hyaluronidase-zzxfGENENTECH INCBLA761170
HELIUM, USPheliumWESTAIR GASES & EQUIPMENT INCNDA214937
MYCAPSSAoctreotide acetateCHIESINDA208232
FINTEPLAfenfluramine hydrochlorideUCB INCNDA212102
GIMOTImetoclopramide hydrochlorideQOL MEDCLNDA209388
TAZVERIKtazemetostat hydrobromideEPIZYME INCNDA213400
LYUMJEVinsulin lispro-aabcELI LILLY AND COBLA761109
ZEPZELCAlurbinectedinJAZZNDA213702
TIVICAY PDdolutegravir sodiumVIIV HLTHCARENDA213983
SEMGLEEinsulin glargineMYLAN PHARMS INCBLA210605
UPLIZNAinebilizumab-cdonVIELA BIOBLA761142
NYVEPRIApegfilgrastim-apgfHOSPIRA INCBLA761111
OXYGEN, USPoxygenAIR LIQUIDE CANADA INCNDA214857
ORIAHNN (COPACKAGED)elagolix sodium,estradiol,norethindrone acetate, elagolix sodiumABBVIENDA213388
TAUVIDflortaucipir f-18AVID RADIOPHARMS INCNDA212123
ZILXIminocycline hydrochlorideJOURNEYNDA213690
ARTESUNATEartesunateAMIVASNDA213036
VESICARE LSsolifenacin succinateASTELLASNDA209529
PHEXXcitric acid, lactic acid, potassium bitartrateEVOFEM INCNDA208352
KYNMOBIapomorphine hydrochlorideSUMITOMO PHARMA AMNDA210875
CERIANNAfluoroestradiol f-18GE HEALTHCARENDA212155
FERRIPROXdeferiproneCHIESINDA212269
IMPEKLOclobetasol propionatePHARMOBEDIENTNDA213691
QINLOCKripretinibDECIPHERA PHARMSNDA213973
RETEVMOselpercatinibELI LILLY AND CONDA213246
TABRECTAcapmatinib hydrochlorideNOVARTIS PHARMNDA213591
ELYXYBcelecoxibSCILEX PHARMSNDA212157
DARZALEX FASPROdaratumumab and hyaluronidase-fihjJANSSEN BIOTECHBLA761145
FENSOLVI KITleuprolide acetateTOLMARNDA213150
MILPROSAprogesteroneFERRING PHARMS INCNDA201110
BAFIERTAMmonomethyl fumarateBANNER LIFE SCIENCESNDA210296
ONGENTYSopicaponeAMNEALNDA212489
TRODELVYsacituzumab govitecan-hziyIMMUNOMEDICS INCBLA761115
EMERPHEDephedrine sulfateNEXUSNDA213407
PEMAZYREpemigatinibINCYTE CORPNDA213736
TUKYSAtucatinibSEAGENNDA213411
JELMYTOmitomycinUROGEN PHARMANDA211728
KOSELUGOselumetinib sulfateASTRAZENECANDA213756
TYBLUMEethinyl estradiol, levonorgestrelEXELTIS USA INCNDA209405
TRIFERIC AVNUferric pyrophosphate citrateROCKWELL MEDICAL INCNDA212860
ZEPOSIAozanimod hydrochlorideBRISTOLNDA209899
PULMOTECH MAAtechnetium tc99m albumin aggregatedCIS BIO INTLBLA210089
ROMIDEPSINromidepsinTEVA PHARMS USA INCNDA208574
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDEbenoxinate hydrochloride, fluorescein sodiumBAUSCH LOMB IRELANDNDA211039
ISTURISAosilodrostat phosphateRECORDATI RARENDA212801
DURYSTAbimatoprostABBVIENDA211911
SARCLISAisatuximab-irfcSANOFI AVENTIS USBLA761113
ADVIL DUAL ACTION WITH ACETAMINOPHENacetaminophen, ibuprofenHALEON US HOLDINGSNDA211733
NURTEC ODTrimegepant sulfatePFIZERNDA212728
BARHEMSYSamisulprideLXO IRELANDNDA209510
NEXLIZETbempedoic acid, ezetimibeESPERION THERAPS INCNDA211617
NEXLETOLbempedoic acidESPERION THERAPS INCNDA211616
VYEPTIeptinezumab-jjmrLundbeck Seattle BioPharmaceuticals, Inc.BLA761119
ANJESOmeloxicamBAUDAXNDA210583
PROCYSBIcysteamine bitartrateHORIZONNDA213491
TWIRLAethinyl estradiol, levonorgestrelAGILENDA204017
PIZENSYlactitolBRAINTREE LABSNDA211281
PEMFEXYpemetrexedEAGLE PHARMSNDA209472
TRIJARDY XRempagliflozin, linagliptin, metformin hydrochlorideBOEHRINGER INGELHEIMNDA212614
DIFICIDfidaxomicinCUBIST PHARMS LLCNDA213138
TAZVERIKtazemetostat hydrobromideEPIZYME INCNDA211723
TEPEZZAteprotumumab-trbwHORIZON THERAPEUTICS IRELANDBLA761143
MONOFERRICferric derisomaltosePHARMACOSMOSNDA208171
RYBELSUSsemaglutideNOVO NORDISK INCNDA213182
NUMBRINOcocaine hydrochlorideOMNIVIUM PHARMSNDA209575
VALTOCOdiazepamNEURELIS INCNDA211635
AYVAKITavapritinibBLUEPRINT MEDICINESNDA212608