All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2019

FDA approved the original submission of 131 new drug and biologics license applications in 2019, from 102 sponsors. FDA marks 21 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
UBRELVYubrogepantABBVIENDA211765
CAPLYTAlumateperone tosylateINTRA-CELLULARNDA209500
DAYVIGOlemborexantEISAI INCNDA212028
ENHERTUfam-trastuzumab deruxtecan-nxkiDAIICHI SANKYOBLA761139
GENOSYLnitric oxideVERO BIOTECH INCNDA202860
TISSUEBLUEbrilliant blue gDUTCH OPHTHALMICNDA209569
CONJUPRIlevamlodipine maleateCSPC OUYINDA212895
ARAZLOtazaroteneBAUSCHNDA211882
PADCEVenfortumab vedotin-ejfvASTELLASBLA761137
NOURESScysteine hydrochlorideBAXTER HLTHCARE CORPNDA212535
VYONDYS 53golodirsenSAREPTA THERAPS INCNDA211970
AVSOLAinfliximab-axxqAMGEN INCBLA761086
REDITREXmethotrexateNORDIC GRPNDA210737
POTASSIUM PHOSPHATESpotassium phosphate, dibasic, potassium phosphate, monobasicFRESENIUS KABI USANDA212832
OXBRYTAvoxelotorGLOBAL BLOOD THERAPSNDA213137
EXSERVANriluzoleAQUESTIVENDA212640
XCOPRIcenobamateSK LIFENDA212839
GIVLAARIgivosiran sodiumALNYLAM PHARMS INCNDA212194
ABRILADAadalimumab-afzbPFIZER INCBLA761118
ADAKVEOcrizanlizumab-tmcaNOVARTIS PHARMS CORPBLA761128
BRUKINSAzanubrutinibBEONE MEDICINES USANDA213217
FETROJAcefiderocol sulfate tosylateSHIONOGINDA209445
REBLOZYLluspatercept-aamtCELGENE CORPBLA761136
EXEM FOAM KITair polymer-type aGISKITNDA212279
ABSORICA LDisotretinoinSUN PHARMNDA211913
EPINEPHRINEepinephrineHOSPIRANDA209359
ZIEXTENZOpegfilgrastim-bmezSANDOZ INCBLA761045
IBRANCEpalbociclibPFIZERNDA212436
TALICIAamoxicillin, omeprazole magnesium, rifabutinTALICIA HOLDINGSNDA213004
VUMERITYdiroximel fumarateBIOGENNDA211855
HELIUM, USPheliumILMO Products CompanyNDA213990
BIORPHENphenylephrine hydrochlorideDR REDDYS LABS SANDA212909
TRIKAFTA (COPACKAGED)elexacaftor, ivacaftor, tezacaftor, ivacaftorVERTEX PHARMS INCNDA212273
AMZEEQminocycline hydrochlorideJOURNEYNDA212379
REYVOWlasmiditan succinateELI LILLY AND CONDA211280
SECUADOasenapineHISAMITSUNDA212268
FLUORODOPA F18fluorodopa f-18FEINSTEINNDA200655
SCENESSEafamelanotideCLIVUNEL INCNDA210797
BEOVUbrolucizumab-dbllNOVARTIS PHARMS CORPBLA761125
AKLIEFtrifaroteneGALDERMA LABS LPNDA211527
BONSITYteriparatideALVOGENNDA211939
BORTEZOMIBbortezomibDR REDDYSNDA206927
QUZYTTIRcetirizine hydrochlorideESTEVENDA211415
HEMADYdexamethasoneDEXCELNDA211379
OZEMPICsemaglutideNOVONDA213051
POTASSIUM PHOSPHATESpotassium phosphate, dibasic, potassium phosphate, monobasicCMP DEV LLCNDA212121
OZOBAX DSbaclofenMETACEL PHARMS LLCNDA208193
IBSRELAtenapanor hydrochlorideARDELYX INCNDA211801
GVOKE KITglucagonXERISNDA212097
FOSAPREPITANT DIMEGLUMINEfosaprepitant dimeglumineTEVA PHARMS USANDA210064
RIOMET ERmetformin hydrochlorideSUN PHARMNDA212595
HARVONIledipasvir, sofosbuvirGILEAD SCIENCES INCNDA212477
SOVALDIsofosbuvirGILEAD SCIENCES INCNDA212480
NOURIANZistradefyllineKYOWA KIRINNDA022075
GALLIUM GA 68 EDOTREOTIDEgallium ga-68 edotreotideUIHC PET IMAGINGNDA210828
CLIGAVYXfulvestrantAVYXA HOLDINGSNDA210063
XENLETAlefamulin acetateHONG KONGNDA211672
XENLETAlefamulin acetateHONG KONGNDA211673
HELIUM, USPheliumA G L WELDING SUPPLY CO INCNDA213727
INREBICfedratinib hydrochlorideBRISTOL-MYERSNDA212327
RINVOQupadacitinibABBVIENDA211675
ROZLYTREKentrectinibGENENTECH INCNDA212725
ROZLYTREKentrectinibGENENTECH INCNDA212726
PRETOMANIDpretomanidMYLAN IRELAND LTDNDA212862
WAKIXpitolisant hydrochlorideHARMONYNDA211150
TURALIOpexidartinib hydrochlorideDAIICHI SANKYO INCNDA211810
NUBEQAdarolutamideBAYER HEALTHCARENDA212099
ACCRUFERferric maltolSHIELD TXNDA212320
ANGIOMAX RTUbivalirudinMAIA PHARMS INCNDA211215
BAQSIMIglucagonAMPHASTAR PHARMS INCNDA210134
HADLIMAadalimumab-bwwdSAMSUNG BIOEPIS CO LTDBLA761059
RUXIENCErituximab-pvvrPFIZER INCBLA761103
DRIZALMA SPRINKLEduloxetine hydrochlorideSUN PHARMNDA212516
ZINC SULFATEzinc sulfateAM REGENTNDA209377
RECARBRIOcilastatin sodium, imipenem, relebactamMSD MERCK CONDA212819
HELIUM, USPheliumROBERTS OXYGEN CO INCNDA213609
KATERZIAamlodipine benzoateAZURITYNDA211340
XPOVIOselinexorKARYOPHARM THERAPSNDA212306
THIOLA ECtioproninMISSION PHARMACALNDA211843
ZIRABEVbevacizumab-bvzrPFIZER INCBLA761099
VYLEESI (AUTOINJECTOR)bremelanotide acetateCOSETTENDA210557
MYXREDLINinsulin humanBAXTER HLTHCARE CORPBLA208157
CARBON DIOXIDE, USPcarbon dioxideA-OX WELDING SUPPLY CO, INC.NDA213507
KANJINTItrastuzumab-annsAMGEN INCBLA761073
ORTIKOSbudesonideSUN PHARM INDS INCNDA211929
POLIVYpolatuzumab vedotin-piiqGENENTECHBLA761121
NUCALAmepolizumabGLAXOSMITHKLINEBLA761122
PIQRAYalpelisibNOVARTISNDA212526
SLYNDdrospirenoneEXELTIS USA INCNDA211367
FULVESTRANTfulvestrantFRESENIUS KABI USANDA210326
NAYZILAMmidazolamUCB INCNDA211321
VYNDAMAXtafamidisFOLDRX PHARMSNDA212161
VYNDAQELtafamidis meglumineFOLDRX PHARMSNDA211996
QTERNMET XRdapagliflozin, metformin hydrochloride, saxagliptin hydrochlorideASTRAZENECA ABNDA210874
SELENIOUS ACIDselenious acidAM REGENTNDA209379
ZURAGARDisopropyl alcoholZUREX PHARMANDA210872
DUOBRIIhalobetasol propionate, tazaroteneBAUSCHNDA209354
ETICOVOetanercept-ykroSAMSUNG BIOEPIS CO LTDBLA761066
SKYRIZIrisankizumab-rzaaABBVIE INCBLA761105
CORLANORivabradineAMGEN INCNDA209964
ELCYScysteine hydrochlorideEXELA PHARMANDA210660
TRANEXAMIC ACIDtranexamic acidEXELA PHARMANDA212020
BALVERSAerdafitinibJANSSEN BIOTECHNDA212018
LEVOTHYROXINE SODIUMlevothyroxine sodiumFRESENIUS KABI USANDA210632
EVENITYromosozumab-aqqgAMGEN INCBLA761062
DOVATOdolutegravir sodium, lamivudineVIIV HLTHCARENDA211994
WELCHOLcolesevelam hydrochlorideCOSETTENDA210895
AVACLYRacyclovirFERA PHARMS LLCNDA202408
DUAKLIR PRESSAIRaclidinium bromide, formoterol fumarateAZURITYNDA210595
MAVENCLADcladribineEMD SERONO INCNDA022561
JATENZOtestosterone undecanoateTOLMARNDA206089
MAYZENTsiponimodNOVARTISNDA209884
SUNOSIsolriamfetol hydrochlorideAXSOME MALTANDA211230
ZULRESSObrexanoloneSAGE THERAP SUPERNUSNDA211371
ZYKADIAceritinibNOVARTISNDA211225
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEefavirenz, lamivudine, tenofovir disoproxil fumarateMACLEODS PHARMSNDA210649
ROCKLATANlatanoprost, netarsudil dimesylateALCON LABS INCNDA208259
TETRACAINE HYDROCHLORIDEtetracaine hydrochlorideBAUSCH LOMB IRELANDNDA210821
TRAZIMERAtrastuzumab-qyypPFIZER INCBLA761081
SPRAVATOesketamine hydrochlorideJANSSEN PHARMSNDA211243
HERCEPTIN HYLECTAtrastuzumab and hyaluronidase-oyskGENENTECH INCBLA761106
ADHANSIA XRmethylphenidate hydrochlorideKNOA PHARMANDA212038
LOTEMAX SMloteprednol etabonateBAUSCH AND LOMB INCNDA208219
TYZAVANvancomycin hydrochlorideHIKMANDA211962
EGATENtriclabendazoleNOVARTISNDA208711
CABLIVIcaplacizumab-yhdpABLYNX NVBLA761112
JEUVEAUprabotulinumtoxina-xvfsEVOLUS INCBLA761085
EVEKEO ODTamphetamine sulfateAZURITYNDA209905
GLOPERBAcolchicineSCILEX PHARMSNDA210942
TOSYMRAsumatriptanTONIX MEDSNDA210884
ONTRUZANTtrastuzumab-dttbSAMSUNG BIOEPIS CO LTDBLA761100