All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2021

FDA approved the original submission of 119 new drug and biologics license applications in 2021, from 103 sponsors. FDA marks 19 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
RECORLEVlevoketoconazoleSTRONGBRIDGENDA214133
CABAZITAXELcabazitaxelACCORD HLTHCARENDA207949
ADBRYtralokinumabLEO PHARMA ASBLA761180
TASCENSO ODTfingolimod lauryl sulfateCYCLENDA214962
LEQVIOinclisiran sodiumNOVARTISNDA214012
APRETUDEcabotegravirVIIV HLTHCARENDA215499
XARELTOrivaroxabanJANSSEN PHARMSNDA215859
ILLUCCIXgallium ga-68 gozetotideTELIXNDA214032
LANREOTIDE ACETATElanreotide acetateINVAGEN PHARMSNDA215395
OXBRYTAvoxelotorGLOBAL BLOOD THERAPSNDA216157
REZVOGLARinsulin glargine-aglrELI LILLY COBLA761215
TEZSPIREtezepelumab-ekkoASTRAZENECA ABBLA761224
VYVGARTefgartigimod alfaARGENX BVBLA761195
YUSIMRYadalimumab-aqvhEMERGE BIOSCIENCE PTE. LTD.BLA761216
DARTISLA ODTglycopyrrolateEDENBRIDGE PHARMSNDA215019
TARPEYObudesonideCALLIDITASNDA215935
ENTADFIfinasteride, tadalafilBLUE WATER BIOTECHNDA215423
XACIATOclindamycin phosphateORGANON LLCNDA215650
CYTALUXpafolacianine sodiumON TARGET LABSNDA214907
LIVTENCITYmaribavirTAKEDA PHARMS USANDA215596
FYARROsirolimusAADINDA213312
LYVISPAHbaclofenSTRIDES PHARMA INTLNDA215422
VOXZOGOvosoritideBIOMARIN PHARMNDA214938
BESREMIropeginterferon alfa-2b-njftPHARMAESSENTIA CORPBLA761166
DHIVYcarbidopa, levodopaAVION PHARMSNDA214869
EPRONTIAtopiramateAZURITYNDA214679
DYANAVEL XR 20amphetamine, amphetamine aspartate/dextroamphetamine sulfateTRIS PHARMA INCNDA210526
SCEMBLIXasciminib hydrochlorideNOVARTISNDA215358
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%diltiazem hydrochlorideEXELA PHARMANDA215252
VUITYpilocarpine hydrochlorideABBVIENDA214028
SUSVIMOranibizumabGENENTECH INCBLA761197
XIPEREtriamcinolone acetonideBAUSCH AND LOMB INCNDA211950
CARBON DIOXIDE, USPcarbon dioxideMIDDLESEX GASES TECHNOLOGIES, INC.NDA216614
SEGLENTIScelecoxib, tramadol hydrochlorideKOWA PHARMSNDA213426
TYRVAYAvarenicline tartrateOYSTER POINT PHARMANDA213978
ZIMHInaloxone hydrochlorideZMI PHARMANDA212854
TAVNEOSavacopanCHEMOCENTRYXNDA214487
SERTRALINE HYDROCHLORIDEsertraline hydrochlorideALMATICANDA215133
LIVMARLImaralixibat chlorideMIRUMNDA214662
QULIPTAatogepantABBVIENDA215206
OPZELURAruxolitinib phosphateINCYTE CORPNDA215309
TIVDAKtisotumab vedotin-tftvSEAGENBLA761208
BYOOVIZranibizumab-nunaSAMSUNG BIOEPIS CO LTDBLA761202
EXKIVITYmobocertinib succinateTAKEDA PHARMS USANDA215310
TRUDHESAdihydroergotamine mesylateIMPEL PHARMSNDA213436
LOREEV XRlorazepamALMATICANDA214826
VANCOMYCINvancomycinHIKMANDA213895
CYCLOPHOSPHAMIDEcyclophosphamideEUGIA PHARMA SPECLTSNDA210735
SKYTROFAlonapegsomatropin-tcgdASCENDIS PHARMA ENCOCRINOLOGY DIV A/SBLA761177
KORSUVAdifelikefalin acetateVIFOR INTLNDA214916
SUCCINYLCHOLINE CHLORIDEsuccinylcholine chlorideHIKMANDA215143
JEMPERLIdostarlimab-gxlyGLAXOSMITHKLINE LLCBLA761223
WELIREGbelzutifanMERCK SHARP DOHMENDA215383
NEXVIAZYMEavalglucosidase alfa-ngptGENZYME CORPBLA761194
MICAFUNGINmicafungin sodiumTEVA PHARMS USA INCNDA212125
SAPHNELOanifrolumab-fniaASTRAZENECA ABBLA761123
UPTRAVIselexipagACTELIONNDA214275
SEMGLEEinsulin glargine-yfgnMYLAN PHARMS INCBLA761201
HELIUM, USPheliumGENERAL AIR SERVICE & SUPPLY COMPANYNDA216307
TWYNEObenzoyl peroxide, tretinoinMAYNE PHARMANDA214902
BYLVAYodevixibatIPSENNDA215498
FEXINIDAZOLEfexinidazoleSANOFINDA214429
REZUROCKbelumosudil mesylateKADMON PHARMS LLCNDA214783
KERENDIAfinerenoneBAYER HLTHCARENDA215341
RYLAZEasparaginase erwinia chrysanthemi (recombinant)-rywnJAZZ PHARMSBLA761179
VERKAZIAcyclosporineHARROW EYENDA214965
DAPTOMYCINdaptomycinHOSPIRANDA210282
PRADAXAdabigatran etexilate mesylateBOEHRINGER INGELHEIMNDA214358
ASTEPRO ALLERGYazelastine hydrochlorideBAYER HLTHCARENDA213872
MICAFUNGINmicafungin sodiumPH HEALTHNDA212156
REZIPRESephedrine hydrochlorideDR REDDYS LABS SANDA213536
SOAANZtorsemideSARFE PHARMSNDA213218
EPCLUSAsofosbuvir, velpatasvirGILEAD SCIENCES INCNDA214187
MAVYRETglecaprevir, pibrentasvirABBVIENDA215110
SODIUM PHENYLACETATE AND SODIUM BENZOATEsodium benzoate, sodium phenylacetateMAIA PHARMS INCNDA215025
ADUHELMaducanumab-avwaBIOGEN INCBLA761178
ARGATROBAN IN SODIUM CHLORIDEargatrobanACCORD HLTHCARENDA212035
TEMBEXAbrincidofovirEMERGENT BIODEFENSENDA214460
TEMBEXAbrincidofovirEMERGENT BIODEFENSENDA214461
WEGOVYsemaglutideNOVONDA215256
BREXAFEMMEibrexafungerp citrateGLAXOSMITHKLINENDA214900
NOXAFIL POWDERMIX KITposaconazoleMSD MERCK CONDA214770
LUMAKRASsotorasibAMGEN INCNDA214665
LYBALVIolanzapine, samidorphan l-malateALKERMES INCNDA213378
TRUSELTIQinfigratinib phosphateHELSINN HLTHCARENDA214622
MYFEMBREEestradiol, norethindrone acetate, relugolixSUMITOMO PHARMA AMNDA214846
PYLARIFYpiflufolastat f-18PROGENICS PHARMS INCNDA214793
CAMCEVI KITleuprolide mesylateACCORDNDA211488
RYBREVANTamivantamab-vmjwJANSSEN BIOTECHBLA761210
LEVOTHYROXINE SODIUMlevothyroxine sodiumHIKMANDA214253
EMPAVELIpegcetacoplanAPELLIS PHARMSNDA215014
ZYNRELEF KITbupivacaine, meloxicamHERON THERAPS INCNDA211988
KLOXXADOnaloxone hydrochlorideHIKMANDA212045
ZYNLONTAloncastuximab tesirine-lpylADC Therapeutics SABLA761196
JEMPERLIdostarlimab-gxlyGLAXOSMITHKLINEBLA761174
NEXTSTELLISdrospirenone, estetrolMAYNE PHARMANDA214154
QELBREEviloxazine hydrochlorideSUPERNUS PHARMSNDA211964
MYRBETRIQ GRANULESmirabegronAPGDINDA213801
ROSZETezetimibe, rosuvastatin calciumALTHERA PHARMSNDA213072
MIDAZOLAM IN 0.9% SODIUM CHLORIDEmidazolamINFORLIFENDA211844
ZEGALOGUEdasiglucagon hydrochlorideZEALAND PHARMANDA214231
PONVORYponesimodVANDA PHARMS INCNDA213498
KIMYRSAoritavancin diphosphateMELINTA THERAPNDA214155
FOTIVDAtivozanib hydrochlorideAVEO PHARMSNDA212904
AZSTARYSdexmethylphenidate hydrochloride, serdexmethylphenidate chlorideCOMMAVE SUBNDA212994
NULIBRYfosdenopterin hydrobromideSENTYNL THERAPS INCNDA214018
AMONDYS 45casimersenSAREPTA THERAPS INCNDA213026
ACETAMINOPHENacetaminophenB BRAUN MEDICALNDA204957
COSELAtrilaciclib dihydrochloridePHARMACOSMOSNDA214200
EVKEEZAevinacumab-dgnbREGENERON PHARMACEUTICALSBLA761181
UKONIQumbralisib tosylateTG THERAPSNDA213176
TEPMETKOtepotinib hydrochlorideEMD SERONO INCNDA214096
POSIMIRbupivacaineINNOCOLLNDA204803
LUPKYNISvoclosporinAURINIANDA213716
CABENUVA KITcabotegravir, rilpivirineVIIV HLTHCARENDA212888
VOCABRIAcabotegravir sodiumVIIV HLTHCARENDA212887
VERQUVOvericiguatMSDNDA214377
ACETAMINOPHENacetaminophenRISINGNDA206610
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEnorepinephrine bitartrateBAXTER HLTHCARE CORPNDA214313