All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2024

FDA approved the original submission of 134 new drug and biologics license applications in 2024, from 107 sponsors. FDA marks 7 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
OPDIVO QVANTIGnivolumab, hyaluronidase-nvhyBRISTOL-MYERS SQUIBBBLA761381
OPDIVO QVANTIGnivolumab, hyaluronidase-nvhyBRISTOL-MYERS SQUIBBBLA761429
TEVIMBRAtislelizumab-jsgrBEIGENEBLA761417
ALHEMOconcizumab-mtciNOVO NORDISK INCBLA761315
ALYFTREKdeutivacaftor, tezacaftor, vanzacaftor calciumVERTEX PHARMS INCNDA218730
TRYNGOLZA (AUTOINJECTOR)olezarsen sodiumIONIS PHARMS INCNDA218614
ENSACOVEensartinib hydrochlorideXCOVERYNDA218171
STEQEYMAustekinumab-stbaCELLTRION, INC.BLA761338
CRENESSITYcrinecerfontNEUROCRINENDA218808
CRENESSITYcrinecerfontNEUROCRINENDA218820
NEMLUVIOnemolizumab-iltoGALDERMA LABS LPBLA761391
UNLOXCYTcosibelimab-ipdlCHECKPOINT THERAPEUTICS INCBLA761297
ONTRALFYtizanidine hydrochlorideFIDELITY BIOPHARMANDA216190
BIZENGRIzenocutuzumab-zbcoMERUS N.V.BLA761352
YESINTEKustekinumab-kfceBIOCON BIOLOGICS INCBLA761406
IOMERVUiomeprolBRACCONDA216016
IOMERVUiomeprolBRACCONDA216017
RALDESYtrazodone hydrochlorideKAMATNDA218637
ATTRUBYacoramidis hydrochlorideBRIDGEBIO PHARMANDA216540
IMKELDIimatinib mesylateSHORLA ONCOLOGYNDA219097
RAPIBLYKlandiolol hydrochlorideAOP HLTH USNDA217202
DAPTOMYCINdaptomycinMAIA PHARMS INCNDA217630
ZIIHERAzanidatamab-hriiJAZZ PHARMSBLA761416
REVUFORJrevumenib citrateSYNDAXNDA218944
Carbon Dioxide, USPcarbon dioxide, uspDJB GAS SERVICES, INCNDA220050
DANZITENnilotinib tartrateAZURITYNDA219293
EMROSIminocycline hydrochlorideJOURNEYNDA219015
ORLYNVAHprobenecid, sulopenem etzadroxilITERUM THERAPNDA213972
BEIZRAYdocetaxelZHUHAINDA218711
VYLOYzolbetuximab-clzbASTELLASBLA761365
VYALEVfoscarbidopa, foslevodopaABBVIENDA216962
HYMPAVZImarstacimab-hncqPFIZER INCBLA761369
IMULDOSAustekinumab-srlfACCORD BIOPHARMA INC.BLA761364
ITOVEBIinavolisibGENENTECH INCNDA219249
PYRIDOSTIGMINE BROMIDEpyridostigmine bromideAMNEALNDA217604
BYNFEZIA PENoctreotide acetateSUN PHARMNDA213224
FLYRCADOflurpiridaz f-18GE HLTHCARENDA215168
OTULFIustekinumab-aauzFRESENIUS KABI USABLA761379
COBENFYtrospium chloride, xanomeline tartrateBRISTOL-MYERSNDA216158
AQNEURSAlevacetylleucineINTRABIONDA219132
MIPLYFFAarimoclomol citrateZEVRA DENMARKNDA214927
EBGLYSSlebrikizumab-lbkzELI LILLY AND COBLA761306
OCREVUS ZUNOVOocrelizumab and hyaluronidase-ocsqGENENTECH INCBLA761371
TECENTRIQ HYBREZAatezolizumab and hyaluronidase-tqjsGENENTECH INCBLA761347
PREVYMISletermovirMSDNDA219104
BORTEZOMIBbortezomibSHILPANDA212782
PAVBLUaflibercept-ayyhAMGEN INCBLA761298
LAZCLUZElazertinib mesylateJANSSEN BIOTECHNDA219008
LIVDELZIseladelpar lysineGILEAD SCIENCES INCNDA217899
NIKTIMVOaxatilimab-csfrINCYTE CORPBLA761411
NEMLUVIOnemolizumab-iltoGALDERMA LABS LPBLA761390
CARBON DIOXIDE, USPcarbon dioxideCENTRAL WELDING SUPPLYNDA219779
ENZEEVUaflibercept-abzvSANDOZ INCBLA761382
NEFFYepinephrineARS PHARMS OPERATIONNDA214697
YORVIPATHpalopegteriparatideASCENDIS PHARMA BONENDA216490
CREXONTcarbidopa, levodopaIMPAXNDA217186
LYMPHIRdenileukin diftitox-cxdlCITIUS PHARMSBLA761312
ZURNAI (AUTOINJECTOR)nalmefene hydrochlorideKNOA PHARMANDA218590
VORANIGOvorasidenibSERVIERNDA218784
TEZRULYterazosin hydrochlorideNOVITIUM PHARMANDA218139
ERZOFRIpaliperidone palmitateLUYE INNOMIND PHARMANDA216352
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDEpotassium phosphate, dibasic, potassium phosphate, monobasicAMNEALNDA218343
ZUNVEYLbenzgalantamine gluconateALPHA COGNITIONNDA218549
LEQSELVIdeuruxolitinib phosphateSUN PHARM INDS INCNDA217900
FEMLYVethinyl estradiol, norethindrone acetateMILLICENT MFG PRNDA218718
OPIPZAaripiprazoleXIAMEN LP PHARM CONDA216655
EPYSQLIeculizumab-aaghSAMSUNG BIOEPIS CO LTDBLA761340
ZITUVIMET XRmetformin hydrochloride, sitagliptinZYDUS LIFESCIENCESNDA216778
VOQUEZNAvonoprazan fumaratePHATHOM PHARMACEUTICALS INCNDA218710
MEDICAL AIR, USPmedical airWSM SUPPLIER LLCNDA219709
VASOPRESSIN IN SODIUM CHLORIDE 0.9%vasopressinLONG GROVE PHARMSNDA217766
KISUNLAdonanemab-azbtELI LILLY COBLA761248
AHZANTIVEaflibercept-mrbbFORMYCON AGBLA761378
AXTLEpemetrexed dipotassiumAVYXA HOLDINGSNDA210661
CHEWTADZYtadalafilB BETTERNDA218527
NYPOZIfilgrastim-txidTANVEX BIOPHARMA USA INCBLA761126
PYZCHIVAustekinumab-ttweSAMSUNG BIOEPIS CO LTDBLA761373
PYZCHIVAustekinumab-ttweSAMSUNG BIOEPIS CO LTDBLA761425
OHTUVAYREensifentrineMSDNDA217389
TEPYLUTEthiotepaSHORLANDA216984
PIASKYcrovalimab-akkzGENENTECH INCBLA761388
SOFDRAsofpironium bromideBOTANIX SBNDA217347
VIGAFYDEvigabatrinPYROS PHARMSNDA217684
IQIRVOelafibranorIPSENNDA218860
RYTELOimetelstat sodiumGERONNDA217779
TERIPARATIDEteriparatideALMAJECTNDA218771
BKEMVeculizumab-aeebAMGEN INCBLA761333
ONYDA XRclonidine hydrochlorideTRIS PHARMA INCNDA217645
OPUVIZaflibercept-yszySAMSUNG BIOEPIS CO LTDBLA761350
YESAFILIaflibercept-jbvfBIOCON BIOLOGICS INCBLA761274
IMDELLTRAtarlatamab-dlleAMGEN INCBLA761344
MYHIBBINmycophenolate mofetilAZURITYNDA216482
INGREZZA SPRINKLEvalbenazine tosylateNEUROCRINENDA218390
RINVOQ LQupadacitinibABBVIENDA218347
XOLREMDImavorixaforX4 PHARMSNDA218709
HERCESSItrastuzumab-strfACCORD BIOPHARMA INC.BLA761346
PIVYApivmecillinam hydrochlorideALEMBIC THERAPNDA216483
VIJOICEalpelisibNOVARTISNDA218466
OJEMDAtovorafenibDAY ONE BIOPHARMSNDA217700
OJEMDAtovorafenibDAY ONE BIOPHARMSNDA218033
ANKTIVAnogapendekin alfa inbakicept-pmlnALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SUBLA761336
LUMIFY PRESERVATIVE FREEbrimonidine tartrateBAUSCH AND LOMB INCNDA218424
REZENOPYnaloxone hydrochlorideSCIENTURENDA215487
ENTYVIOvedolizumabTAKEDA PHARMS USABLA761359
LUMISIGHTpegulicianine acetateLUMICELLNDA214511
SELARSDIustekinumab-aeknALVOTECH USA INCBLA761343
ENTRESTO SPRINKLEsacubitril, valsartanNOVARTISNDA218591
RETEVMOselpercatinibELI LILLY AND CONDA218160
XROMIhydroxyureaNOVA LABS LTDNDA216593
ZEVTERAceftobiprole medocaril sodiumISTXNDA218275
RISVANrisperidoneLABS FARMS ROVI SANDA214835
VOYDEYAdanicopanALEXION PHARMS INCNDA218037
VAFSEOvadadustatAKEBIANDA215192
WINREVAIRsotatercept-csrkMERCK SHARP DOHMEBLA761363
OPSYNVImacitentan, tadalafilACTELIONNDA218490
DUVYZATgivinostat hydrochlorideITALFARMACO SPANDA217865
TRYVIOaprocitentanIDORSIANDA217686
EDURANT PEDrilpivirine hydrochlorideJANSSEN PRODSNDA219016
CABAZITAXELcabazitaxelACTAVISNDA207970
REZDIFFRAresmetiromMADRIGALNDA217785
TEVIMBRAtislelizumab-jsgrBEIGENEBLA761232
TALZENNAtalazoparib tosylatePFIZERNDA217439
JUBBONTIdenosumab-bbdzSANDOZ INCBLA761362
TYENNEtocilizumab-aazgFRESENIUS KABI USABLA761275
BYQLOVIclobetasol propionateHARROW EYENDA218158
LETYBOletibotulinumtoxina-wlbgHUGEL INCBLA761225
SIMLANDIadalimumab-ryvkALVOTECH USA INCBLA761299
EXBLIFEPcefepime hydrochloride, enmetazobactamORCHID PHARMANDA216165
CARBON DIOXIDE, USPcarbon dioxideHAUN SPECIALTY GASES INCNDA219303
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDEpantoprazole sodiumBAXTER HLTHCARE CORPNDA217512
AURLUMYNiloprostBTG INTLNDA217933
LEGUBETIacetylcysteine lysineGALEPHARNDA215040
EOHILIAbudesonideTAKEDA PHARMS USANDA213976
ZELSUVMIberdazimer sodiumLNHCNDA217424