All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2018

FDA approved the original submission of 152 new drug and biologics license applications in 2018, from 123 sponsors. FDA marks 33 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
ELZONRIStagraxofusp-erzsSTEMLINE THERAPEUTICS INCBLA761116
INBRIJAlevodopaMERZNDA209184
ULTOMIRISravulizumab-cwvzALEXION PHARMBLA761108
ASPARLAScalaspargase pegol-mknlSERVIER PHARMA LLCBLA761102
ELEPSIA XRlevetiracetamTRIPOINTNDA204417
LICARTdiclofenac epolamineIBSA INST BIONDA206976
EZALLOR SPRINKLErosuvastatin calciumSUN PHARMNDA208647
HERZUMAtrastuzumab-pkrbCELLTRION INCBLA761091
MOTEGRITYprucalopride succinateTAKEDA PHARMS USANDA210166
TOLSURAitraconazoleMAYNE PHARMANDA208901
DEXTENZAdexamethasoneOCULAR THERAPEUTIXNDA208742
FIRDAPSEamifampridine phosphateCATALYST PHARMSNDA208078
TRUXIMArituximab-abbsCELLTRION INCBLA761088
XOSPATAgilteritinib fumarateASTELLASNDA211349
ARGATROBAN IN SODIUM CHLORIDEargatrobanEUGIA PHARMA SPECLTSNDA209552
VITRAKVIlarotrectinib sulfateBAYER HLTHCARENDA210861
VITRAKVIlarotrectinib sulfateBAYER HEALTHCARENDA211710
DAURISMOglasdegib maleatePFIZERNDA210656
SPY AGENT GREEN KITindocyanine greenNOVADAQ TECHNDA211580
GAMIFANTemapalumab-lzsgNOVIMMUNE S.A.BLA761107
READYPREP CHGchlorhexidine gluconateMEDLINE INDUSTRIESNDA207964
AEMCOLOrifamycin sodiumCOSMO TECHNOLOGIESNDA210910
TEMIXYSlamivudine, tenofovir disoproxil fumarateCHARTWELL RXNDA211284
YUPELRIrevefenacinMYLAN IRELAND LTDNDA210598
PRIMATENE MISTepinephrineARMSTRONG PHARMSNDA205920
BRYHALIhalobetasol propionateBAUSCHNDA209355
DSUVIAsufentanil citrateVERTICAL PHARMSNDA209128
LORBRENAlorlatinibPFIZERNDA210868
UDENYCApegfilgrastim-cbqvCOHERUS BIOSCIENCES INCBLA761039
SYMPAZANclobazamCOSETTENDA210833
HYRIMOZadalimumab-adazSANDOZ INCBLA761071
CALCIUM GLUCONATEcalcium gluconateHQ SPCLT PHARMANDA210906
BIJUVAestradiol, progesteroneMAYNE PHARMANDA210132
XOFLUZAbaloxavir marboxilGENENTECH INCNDA210854
KHAPZORYlevoleucovorinACROTECH BIOPHARMANDA211226
QMIIZ ODTmeloxicamTERSERANDA211210
HELIUM, USPheliumMATHESON TRI-GAS INCNDA212539
TALZENNAtalazoparib tosylatePFIZERNDA211651
YUTIQfluocinolone acetonideALIMERA SCIENCES INCNDA210331
REVCOVIelapegademase-lvlrCHIESI USA INCBLA761092
TEGSEDIinotersen sodiumAKCEA THERAPSNDA211172
NUZYRAomadacycline tosylatePARATEK PHARMSNDA209816
NUZYRAomadacycline tosylatePARATEK PHARMSNDA209817
SEYSARAsarecycline hydrochlorideALMIRALLNDA209521
ARIKAYCE KITamikacin sulfateINSMED INCNDA207356
LIBTAYOcemiplimab-rwlcREGENERON PHARMACEUTICALSBLA761097
XYOSTED (AUTOINJECTOR)testosterone enanthateANTARES PHARMA INCNDA209863
EMGALITYgalcanezumab-gnlmELI LILLY AND COBLA761063
VIZIMPROdacomitinibPFIZERNDA211288
COPIKTRAduvelisibSECURANDA211155
AJOVYfremanezumab-vfrmTEVA PHARMS USABLA761089
SEIZALAMmidazolam hydrochlorideMMTNDA209566
LUMOXITImoxetumomab pasudotox-tdfkINNATE PHARMABLA761104
XELPROSlatanoprostSUN PHARMNDA206185
OXYGEN, USPoxygenCRISTAL ASU LLCNDA211739
CASSIPAbuprenorphine hydrochloride, naloxone hydrochlorideTEVA PHARMS USANDA208042
TIGLUTIK KITriluzoleITALFARMACO SANDA209080
DELSTRIGOdoravirine, lamivudine, tenofovir disoproxil fumarateMSD MERCK CONDA210807
PIFELTROdoravirineMSD MERCK CONDA210806
LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONleuprolide acetateINVAGEN PHARMSNDA205054
XERAVAeravacycline dihydrochlorideTETRAPHASE PHARMSNDA211109
NITROGEN, NFnitrogen, nfUNIVERSAL INDUSTRIAL GASES, INCNDA212315
OXYGEN, USPoxygenUNIVERSAL INDUSTRIAL GASES, INCNDA212314
ALTRENOtretinoinDOW PHARMNDA209353
TAKHZYROlanadelumab-flyoDYAX CORP.BLA761090
INVELTYSloteprednol etabonateALCON LABS INCNDA210565
OXERVATEcenegermin-bkbjDOMPE FARMACEUTICIBLA761094
DIACOMITstiripentolBIOCODEX SANDA206709
DIACOMITstiripentolBIOCODEX SANDA207223
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEefavirenz, lamivudine, tenofovir disoproxil fumarateAUROBINDO PHARMA LTDNDA022343
CEQUAcyclosporineSUN PHARMNDA210913
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINElamivudine, nevirapine, zidovudineMICRO LABSNDA205626
ANNOVERAethinyl estradiol, segesterone acetateMAYNE PHARMANDA209627
GALAFOLDmigalastat hydrochlorideAMICUS THERAP USNDA208623
ONPATTROpatisiran sodiumALNYLAM PHARMS INCNDA210922
ARAKODAtafenoquine succinate60 DEGREES PHARMSNDA210607
JORNAY PMmethylphenidate hydrochlorideIRONSHORE PHARMSNDA209311
POTELIGEOmogamulizumab-kpkcKYOWA KIRINBLA761051
SOLUPREP Schlorhexidine gluconate, isopropyl alcoholSOLVENTUMNDA208288
ORKAMBIivacaftor, lumacaftorVERTEX PHARMS INCNDA211358
TIGECYCLINEtigecyclineAMNEALNDA211158
MULPLETAlusutrombopagVANCOCIN ITALIANDA210923
AZEDRAiobenguane i-131PROGENICS PHARMS INCNDA209607
REMODULINtreprostinilUNITED THERAPNDA208276
OMEGAVENfish oil triglyceridesFRESENIUS KABI USANDA210589
PERSERIS KITrisperidoneINDIVIORNDA210655
DOXERCALCIFEROLdoxercalciferolHOSPIRANDA208614
ORILISSAelagolix sodiumABBVIENDA210450
KRINTAFELtafenoquine succinateGLAXOSMITHKLINENDA210795
NIVESTYMfilgrastim-aafiHOSPIRA INCBLA761080
TIBSOVOivosidenibSERVIERNDA211192
SYMTUZAcobicistat, darunavir, emtricitabine, tenofovir alafenamide fumarateJANSSEN PRODSNDA210455
INFUGEMgemcitabine hydrochlorideSUN PHARMNDA208313
TPOXXtecovirimatSIGA TECHNOLOGIESNDA208627
GLYRX-PFglycopyrrolateEXELA PHARMANDA210997
VANCOMYCIN HYDROCHLORIDEvancomycin hydrochlorideMYLAN LABS LTDNDA209481
ATROPINE (AUTOINJECTOR)atropineRAFA LABS LTDNDA212319
ARISTADA INITIO KITaripiprazole lauroxilALKERMES INCNDA209830
NUPLAZIDpimavanserin tartrateACADIA PHARMS INCNDA210793
QBREXZAglycopyrronium tosylateJOURNEYNDA210361
BRAFTOVIencorafenibARRAY BIOPHARMA INCNDA210496
MEKTOVIbinimetinibARRAY BIOPHARMA INCNDA210498
EPIDIOLEXcannabidiolJAZZ PHARMS RESNDA210365
ZEMDRIplazomicin sulfateCIPLA USANDA210303
ABLYSINOLdehydrated alcoholBPI LABSNDA207987
NOCDURNAdesmopressin acetateFERRING PHARMS INCNDA022517
LYMEPAKdoxycycline hyclateCHARTWELL PHARMANDA209844
MOXIDECTINmoxidectinMDGHNDA210867
FULPHILApegfilgrastim-jmdbMYLAN GMBHBLA761075
CONSENSIamlodipine besylate, celecoxibPURPLE BIOTECHNDA210045
OLUMIANTbaricitinibELI LILLY AND CONDA207924
IMVEXXYestradiolMAYNE PHARMANDA208564
LEXETTEhalobetasol propionateMAYNE PHARMANDA210566
PALYNZIQpegvaliase-pqpzBIOMARIN PHARMBLA761079
PROGRAFtacrolimusASTELLASNDA210115
YONSAabiraterone acetateSUN PHARMNDA210308
DOPTELETavatrombopag maleateAKARX INCNDA210238
LOKELMAsodium zirconium cyclosilicateASTRAZENECANDA207078
AIMOVIGerenumab-aooeAMGEN INCBLA761077
LUCEMYRAlofexidine hydrochlorideBIOCORRX PHARMSNDA209229
BELRAPZObendamustine hydrochlorideEAGLE PHARMSNDA205580
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATElamivudine, tenofovir disoproxil fumarateAUROBINDO PHARMA LTDNDA022344
RETACRITepoetin alfa-epbxHOSPIRA INCBLA125545
PLENVUascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, sodium sulfateNORGINENDA209381
XTRELUSguaifenesin, hydrocodone bitartrateECI PHARMS LLCNDA208085
HELIUM, USPheliumA-OX WELDING SUPPLY CO, INC.NDA211781
JYNARQUEtolvaptanOTSUKANDA204441
AKYNZEOfosnetupitant chloride hydrochloride, palonosetron hydrochlorideHELSINN HLTHCARENDA210493
CRYSVITAburosumab-twzaKYOWA KIRINBLA761068
TAVALISSEfostamatinib disodiumRIGEL PHARMSNDA209299
NITROGEN, NFnitrogenCRISTAL ASU LLCNDA211737
SYMFIefavirenz, lamivudine, tenofovir disoproxil fumarateMYLAN LABS LTDNDA022142
ILUMYAtildrakizumab-asmnSUN PHARMA GLOBALBLA761067
TROGARZOibalizumab-uiykTHERATECHNOLOGIESBLA761065
CIMDUOlamivudine, tenofovir disoproxil fumarateMYLAN LABS LTDNDA022141
ZTLIDOlidocaineSCILEX PHARMSNDA207962
VERZENIOabemaciclibELI LILLY AND CONDA208855
APADAZacetaminophen, benzhydrocodone hydrochlorideZEVRA THERAPNDA208653
IMBRUVICAibrutinibPHARMACYCLICS LLCNDA210563
OSMOLEX ERamantadine hydrochlorideSUPERNUS PHARMSNDA209410
ERLEADAapalutamideJANSSEN BIOTECHNDA210951
SYMDEKO (COPACKAGED)ivacaftor, ivacaftor, tezacaftorVERTEX PHARMS INCNDA210491
DEXYCU KITdexamethasoneEYEPOINT PHARMSNDA208912
RADIOGENIX SYSTEMtechnetium tc-99m sodium pertechnetate generatorNORTHSTAR MEDICALNDA202158
BIKTARVYbictegravir sodium, emtricitabine, tenofovir alafenamide fumarateGILEAD SCIENCES INCNDA210251
SYMFI LOefavirenz, lamivudine, tenofovir disoproxil fumarateMYLANNDA208255
ATROPINE SULFATEatropine sulfateFRESENIUS KABI USANDA209260
FIRVANQ KITvancomycin hydrochlorideAZURITYNDA208910
KAPSPARGO SPRINKLEmetoprolol succinateSPILNDA210428
LUTATHERAlutetium lu 177 dotatateAAA USA INCNDA208700
TIGECYCLINEtigecyclineACCORD HLTHCARE INCNDA208744
BALCOLTRAethinyl estradiol, levonorgestrelAVION PHARMSNDA208612