All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2022

FDA approved the original submission of 123 new drug and biologics license applications in 2022, from 97 sponsors. FDA marks 14 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
BRIUMVIublituximab-xiiyTG THERAPEUTICS, INCBLA761238
NEXOBRIDanacaulase-bcdbMEDIWOUND, LTDBLA761192
XENOVIEWxenon xe-129 hyperpolarizedPOLAREANNDA214375
LUNSUMIO VELOmosunetuzumab-axgbGENENTECH INCBLA761263
OLPRUVAsodium phenylbutyrateACERNDA214860
SUNLENCAlenacapavir sodiumGILEAD SCIENCES INCNDA215973
SUNLENCAlenacapavir sodiumGILEAD SCIENCES INCNDA215974
BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideHOSPIRANDA211530
BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideBAXTER HLTHCARE CORPNDA216078
IDACIOadalimumab-aacfFRESENIUS KABI USABLA761255
IYUZEHlatanoprostTHEA PHARMANDA216472
KRAZATIadagrasibBRISTOLNDA216340
BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideAPOTEXNDA215033
VIVIMUSTAbendamustine hydrochlorideAZURITYNDA212209
REZLIDHIAolutasidenibRIGEL PHARMSNDA215814
JYLAMVOmethotrexateSHORLANDA212479
DOCETAXELdocetaxelAVYXA HOLDINGSNDA215813
SINCALIDEsincalideMAIA PHARMS INCNDA210850
SEZABYphenobarbital sodiumSUN PHARM INDS INCNDA215910
TZIELDteplizumab-mzwvPROVENTION BIO INCBLA761183
ELAHEREmirvetuximab soravtansine-gynxIMMUNOGEN INCBLA761310
IMJUDOtremelimumab-actlASTRAZENECA ABBLA761270
TECVAYLIteclistamab-cqyvJANSSEN BIOTECHBLA761291
IMJUDOtremelimumab-actlASTRAZENECA ABBLA761289
CEFAZOLIN SODIUMcefazolin sodiumHIKMANDA216109
FUROSCIXfurosemideSCPHARMACEUTICALSNDA209988
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEnorepinephrine bitartrateLONG GROVE PHARMSNDA214628
LYTGOBIfutibatinibTAIHO ONCOLOGYNDA214801
RELYVRIOsodium phenylbutyrate, taurursodiolAMYLYXNDA216660
IHEEZOchloroprocaine hydrochlorideHARROW EYENDA216227
VEGZELMAbevacizumab-adcdCELLTRIONBLA761268
OMLONTIomidenepag isopropylOCUVEX THERAPNDA215092
ELUCIREMgadopiclenolGUERBETNDA216986
PEDMARKsodium thiosulfateFENNEC PHARMS INCNDA212937
APONVIEaprepitantHERON THERAPS INCNDA216457
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEnorepinephrine bitartrateINFORLIFENDA215700
TERLIVAZterlipressin acetateMALLINCKRODT IRELANDNDA022231
ROLVEDONeflapegrastim-xnstSPECTRUM PHARMSBLA761148
SOTYKTUdeucravacitinibBRISTOLNDA214958
DAXXIFYdaxibotulinumtoxina-lanmREVANCE THERAPEUTICS, INC.BLA761127
SPEVIGOspesolimab-sbzoBOEHRINGER INGELHEIM PHARMACEUTICALS INCBLA761244
STIMUFENDpegfilgrastim-fpgkFRESENIUS KABI USABLA761173
XENPOZYMEolipudase alfa-rpcpGENZYME CORPBLA761261
KONVOMEPomeprazole, sodium bicarbonateAZURITYNDA213593
IMBRUVICAibrutinibPHARMACYCLICS LLCNDA217003
AUVELITYbupropion hydrochloride, dextromethorphan hydrobromideAXSOMENDA215430
EPINEPHRINEepinephrineINTL MEDICATION SYSNDA211363
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)midazolam hydrochlorideRAFA LABS LTDNDA216359
CALQUENCEacalabrutinib maleateASTRAZENECANDA216387
CIMERLIranibizumab-eqrnSANDOZ INCBLA761165
ZORYVEroflumilastARCUTISNDA215985
BORTEZOMIBbortezomibMAIA PHARMS INCNDA215331
KYZATREXtestosterone undecanoateMARIUSNDA213953
PACLITAXELpaclitaxelAM REGENTNDA211875
BORTEZOMIBbortezomibACCORD HLTHCARENDA215441
MIDAZOLAM IN 0.8% SODIUM CHLORIDEmidazolamEXELA PHARMANDA215868
PEMETREXED DISODIUMpemetrexed disodiumACCORD HLTHCARENDA214408
ZONISADEzonisamideAZURITYNDA214273
BLUDIGOindigotindisulfonate sodiumPROVEPHARM SASNDA216264
DROSPIRENONEdrospirenoneEXELTIS USA INCNDA216285
VENLAFAXINE BESYLATEvenlafaxine besylateALMATICANDA215429
RELEXXIImethylphenidate hydrochlorideOSMOTICA PHARM USNDA216117
PEMETREXED DISODIUMpemetrexed disodiumHOSPIRANDA214218
PHEBURANEsodium phenylbutyrateMEDUNIKNDA216513
TADLIQtadalafilCMP DEV LLCNDA214522
SKYRIZIrisankizumab-rzaaABBVIE INCBLA761262
AMVUTTRAvutrisiran sodiumALNYLAM PHARMS INCNDA215515
Nitrogen, NFnitrogenABSOLUTE AIR, LLCNDA217499
OXYGEN, USPoxygenABSOLUTE AIR, LLCNDA217500
PEMETREXED DITROMETHAMINEpemetrexed ditromethamineHOSPIRANDA208746
ACETAMINOPHENacetaminophenHIKMANDA206968
AZMIROtestosterone cypionateAZURITYNDA216318
FYLNETRApegfilgrastim-pbbkKASHIV BIOSCIENCES LLCBLA761084
PEMETREXED DISODIUMpemetrexed disodiumSANDOZNDA214657
TYVASO DPItreprostinilUNITED THERAPNDA214324
VTAMAtapinarofORGANON LLCNDA215272
TPOXXtecovirimatSIGA TECHNOLOGIESNDA214518
CARMUSTINEcarmustineACCORD HLTHCARENDA215000
MOUNJAROtirzepatideELI LILLY AND CONDA215866
RADICAVA ORSedaravoneSHIONOGINDA215446
VOQUEZNA DUAL PAKamoxicillin, vonoprazan fumaratePHATHOMNDA215153
VOQUEZNA TRIPLE PAKamoxicillin, clarithromycin, vonoprazan fumaratePHATHOMNDA215152
BORTEZOMIBbortezomibHOSPIRANDA209191
ERMEZAlevothyroxine sodiumMYLANNDA215809
CAMZYOSmavacamtenBRISTOLNDA214998
CUVRIORtrientine tetrahydrochlorideORPHALANNDA215760
CARBON DIOXIDE, USPcarbon dioxideLINDE GAS EQUIPNDA217332
VIVJOAoteseconazoleMYCOVIA PHARMSNDA215888
EPSOLAYbenzoyl peroxideMAYNE PHARMANDA214510
GLYCOPYRROLATEglycopyrrolateFRESENIUS KABI USANDA214919
ALYMSYSbevacizumab-malyAMNEAL PHARMS LLCBLA761231
IGALMIdexmedetomidine hydrochlorideBIOXCELNDA215390
VIJOICEalpelisibNOVARTISNDA215039
TRIUMEQ PDabacavir sulfate, dolutegravir sodium, lamivudineVIIV HLTHCARENDA215413
TLANDOtestosterone undecanoateVERITYNDA208088
LOCAMETZgallium ga-68 gozetotideNOVARTISNDA215841
PLUVICTOlutetium lu-177 vipivotide tetraxetanNOVARTISNDA215833
HYFTORsirolimusNOBELPHARMANDA213478
XELSTRYMdextroamphetamineNOVEN PHARMS INCNDA215401
OPDUALAGnivolumab, relatlimab-rmbwBRISTOL MYERS SQUIBBBLA761234
ZTALMYganaxoloneIMMEDICA PHARMANDA215904
NASONEX 24HR ALLERGYmometasone furoatePERRIGO PHARMA INTLNDA215712
ATROPINE SULFATEatropine sulfateBAUSCH AND LOMB INCNDA213581
ADLARITYdonepezil hydrochlorideCORIUMNDA212304
ASPRUZYO SPRINKLEranolazineSPILNDA216018
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)naloxone hydrochlorideKALEO INCNDA215457
VONJOpacritinib citrateSOBINDA208712
ACUVUE THERAVISION WITH KETOTIFENketotifen fumarateJOHNSON JOHNSON VISNNDA022388
CARBON DIOXIDE, USPcarbon dioxideCONTINENTAL CARBONIC PRODUCTS, INC.NDA217082
RELEUKOfilgrastim-ayowKASHIV BIOSCIENCES LLCBLA761082
NORLIQVAamlodipine besylateCMP DEV LLCNDA214439
NEPHROSCANtechnetium tc-99m succimerTHERAGNOSTICSNDA214993
PYRUKYNDmitapivat sulfateAGIOS PHARMS INCNDA216196
ENJAYMOsutimlimab-jomeRECORDATI RARE DISEASES, INC.BLA761164
FLEQSUVYbaclofenAZURITYNDA215602
CITALOPRAM HYDROBROMIDEcitalopram hydrobromideALMATICANDA215428
VABYSMOfaricimab-svoaGENENTECH INCBLA761235
DAPTOMYCIN IN 0.9% SODIUM CHLORIDEdaptomycinBAXTER HLTHCARE CORPNDA213645
KIMMTRAKtebentafusp-tebnIMMUNOCORE LTDBLA761228
CIBINQOabrocitinibPFIZERNDA213871
SOVUNAhydroxychloroquine sulfateNOVITIUM PHARMANDA214581
RYALTRISmometasone furoate, olopatadine hydrochlorideGLENMARK SPECLTNDA211746
QUVIVIQdaridorexant hydrochlorideIDORSIANDA214985