All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2017

FDA approved the original submission of 145 new drug and biologics license applications in 2017, from 112 sponsors. FDA marks 29 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
LUMIFYbrimonidine tartrateBAUSCH AND LOMB INCNDA208144
BIVALIRUDIN IN 0.9% SODIUM CHLORIDEbivalirudinBAXTER HLTHCARE CORPNDA208374
GIAPREZAangiotensin ii acetateLA JOLLA PHARMANDA209360
SIKLOShydroxyureaTHERAVIANDA208843
MACRILENmacimorelin acetateAETERNA ZENTARISNDA205598
PREXXARTANvalsartanCARMEL BIOSCIENCESNDA209139
SEGLUROMETertugliflozin, metformin hydrochlorideMSD SUB MERCKNDA209806
STEGLATROertugliflozinMSD SUB MERCKNDA209803
STEGLUJANertugliflozin, sitagliptin phosphateMSD SUB MERCKNDA209805
RHOPRESSAnetarsudil mesylateALCON LABS INCNDA208254
MEDICAL AIR, USPmedical airLINDE GAS PUERTO RICO INCNDA211270
ALTAFLUOR BENOXbenoxinate hydrochloride, fluorescein sodiumALTAIRE PHARMS INCNDA208582
ESKATAhydrogen peroxideACLARISNDA209305
GOPRELTOcocaine hydrochlorideLXO IRELANDNDA209963
IXIFIinfliximab-qbtxPFIZER INCBLA761072
ADMELOGinsulin lisproSANOFI-AVENTIS USBLA209196
XEPIozenoxacinLNHCNDA208945
SINUVAmometasone furoateINTERSECT ENT INCNDA209310
LONHALA MAGNAIR KITglycopyrrolateSUMITOMO PHARMA AMNDA208437
OZEMPICsemaglutideNOVONDA209637
OGIVRItrastuzumab-dkstMYLAN GMBHBLA761074
SUBLOCADEbuprenorphineINDIVIORNDA209819
CLENPIQcitric acid, magnesium oxide, sodium picosulfateFERRING PHARMS INCNDA209589
IMPOYZclobetasol propionatePRIMUS PHARMSNDA209483
JULUCAdolutegravir sodium, rilpivirine hydrochlorideVIIV HLTHCARENDA210192
PALONOSETRON HYDROCHLORIDEpalonosetron hydrochlorideFRESENIUS KABI USANDA208109
HEMLIBRAemicizumabGENENTECH INCBLA761083
MEPSEVIIvestronidase alfa-vjbkULTRAGENYX PHARM INCBLA761047
FASENRAbenralizumabASTRAZENECA ABBLA761070
TEKTURNAaliskiren hemifumarateNODEN PHARMANDA210709
ABILIFY MYCITE KITaripiprazoleOTSUKANDA207202
CINVANTIaprepitantHERON THERAPS INCNDA209296
PREVYMISletermovirMERCK SHARP DOHMENDA209939
PREVYMISletermovirMERCK SHARP DOHMENDA209940
BORTEZOMIBbortezomibFRESENIUS KABI USANDA205004
VYZULTAlatanoprostene bunodBAUSCH AND LOMBNDA207795
CALQUENCEacalabrutinibASTRAZENECANDA210259
VARUBIrolapitant hydrochlorideTERSERANDA208399
BYDUREON BCISEexenatide syntheticASTRAZENECA ABNDA209210
DAPTOMYCINdaptomycinHIKMANDA209949
LYRICA CRpregabalinUPJOHNNDA209501
ZILRETTAtriamcinolone acetonidePACIRA PHARMS INCNDA208845
ASCORascorbic acidMCGUFFNDA209112
FIASP PENFILLinsulin aspartNOVOBLA208751
VERZENIOabemaciclibELI LILLY AND CONDA208716
CLOROTEKALchloroprocaine hydrochlorideB BRAUN MEDICALNDA208791
TRELEGY ELLIPTAfluticasone furoate, umeclidinium bromide, vilanterol trifenatateGLAXOSMITHKLINENDA209482
XHANCEfluticasone propionatePARATEK PHARMSNDA209022
ADZENYS ERamphetamineNEOS THERAPS INCNDA204325
SOLOSECsecnidazoleEVOFEM INCNDA209363
ALIQOPAcopanlisib dihydrochlorideBAYER HEALTHCARENDA209936
MVASIbevacizumab-awwbAMGEN INCBLA761028
DAPTOMYCINdaptomycinSAGENT PHARMS INCNDA208385
TRACLEERbosentanACTELIONNDA209279
OXYGEN, USPoxygenPRAXAIR MEXICONDA210844
MYLOTARGgemtuzumab ozogamicinWYETH PHARMS INCBLA761060
AUSTEDOdeutetrabenazineTEVA BRANDED PHARMNDA209885
BENZNIDAZOLEbenznidazoleCHEMO RESEARCH SLNDA209570
VABOMEREmeropenem, vaborbactamREMPEXNDA209776
CYLTEZOadalimumab-adbmBOEHRINGER INGELHEIMBLA761058
GOCOVRIamantadine hydrochlorideSUPERNUS PHARMSNDA208944
CARBON DIOXIDE, USPcarbon dioxideLISS AMERICA LLCNDA210816
DUZALLOallopurinol, lesinuradIRONWOOD PHARMS INCNDA209203
BESPONSAinotuzumab ozogamicinWYETH PHARMS INCBLA761040
DRAX EXAMETAZIMEtechnetium tc-99m exametazime kitJUBILANTNDA208870
LYNPARZAolaparibASTRAZENECANDA208558
CAROSPIRspironolactoneCMP DEV LLCNDA209478
NIKITApitavastatin sodiumLUPINNDA209875
GEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideACCORD HLTHCARENDA209604
MAVYRETglecaprevir, pibrentasvirABBVIENDA209394
QVAR REDIHALERbeclomethasone dipropionateNORTON WATERFORDNDA207921
VYXEOScytarabine, daunorubicinJAZZ PHARMS THERAPNDA209401
IDHIFAenasidenib mesylateBRISTOL MYERS SQUIBBNDA209606
HARLIKUnitisinoneCYCLENDA209449
BENLYSTAbelimumabGLAXOSMITHKLINE LLCBLA761043
VOSEVIsofosbuvir, velpatasvir, voxilaprevirGILEAD SCIENCES INCNDA209195
NERLYNXneratinib maleatePUMA BIOTECHNDA208051
ZYPITAMAGpitavastatin magnesiumMEDICURENDA208379
TREMFYAguselkumabJANSSEN BIOTECHBLA761061
ENDARIl-glutamineEMMAUS MEDCLNDA208587
OMEPRAZOLEomeprazoleDEXCELNDA209400
PANTOPRAZOLE SODIUMpantoprazole sodiumHIKMANDA209463
TRIPTODUR KITtriptorelin pamoateAZURITYNDA208956
BEVYXXAbetrixabanPORTOLA PHARMS INCNDA208383
RITUXAN HYCELArituximab, hyaluronidase (human recombinant)GENENTECH INCBLA761064
MYDAYISamphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfateTAKEDA PHARMS USANDA022063
BAXDELAdelafloxacin meglumineMELINTANDA208610
BAXDELAdelafloxacin meglumineMELINTANDA208611
COTEMPLA XR-ODTmethylphenidateNEOS THERAPS INCNDA205489
CALCIUM GLUCONATEcalcium gluconateFRESENIUS KABI USANDA208418
SYMJEPIepinephrineADAMIS PHARMS CORPNDA207534
NORVIRritonavirABBVIENDA209512
GLEOLANaminolevulinic acid hydrochlorideNXDCNDA208630
ZERVIATEcetirizine hydrochlorideHARROW EYENDA208694
KEVZARAsarilumabSANOFI SYNTHELABOBLA761037
JADENU SPRINKLEdeferasiroxNOVARTISNDA207968
BAVENCIOavelumabEMD SERONO INCBLA761078
MINOLIRAminocycline hydrochlorideEPI HLTHNDA209269
RADICAVAedaravoneSHIONOGINDA209176
KISQALI FEMARA CO-PACK (COPACKAGED)letrozole, ribociclib succinateNOVARTISNDA209935
IMFINZIdurvalumabASTRAZENECA UK LTDBLA761069
STERITALCtalcNOVATECH SANDA205555
ALUNBRIGbrigatinibTAKEDA PHARMS USANDA208772
RYDAPTmidostaurinNOVARTISNDA207997
TYMLOSabaloparatideRADIUSNDA208743
BRINEURAcerliponase alfaBIOMARIN PHARMBLA761052
XATMEPmethotrexate sodiumAZURITYNDA208400
RENFLEXISinfliximab-abdaSAMSUNG BIOEPIS CO LTDBLA761054
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDEclindamycin phosphateBAXTER HLTHCARE CORPNDA208083
ROXYBONDoxycodone hydrochloridePROTEGA PHARMSNDA209777
INGREZZAvalbenazine tosylateNEUROCRINENDA209241
AUSTEDOdeutetrabenazineTEVA BRANDED PHARMNDA208082
DUPIXENTdupilumabREGENERON PHARMACEUTICALSBLA761055
OCREVUSocrelizumabGENENTECH INCBLA761053
ZEJULAniraparib tosylateGLAXOSMITHKLINENDA208447
BAVENCIOavelumabEMD SERONO INCBLA761049
SYMPROICnaldemedine tosylateBDSINDA208854
XADAGOsafinamide mesylateMDD USNDA207145
LAMIVUDINE AND ZIDOVUDINElamivudine, zidovudinePHARMACARENDA022018
KISQALIribociclib succinateNOVARTISNDA209092
VORICONAZOLEvoriconazoleHIKMANDA208562
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%sodium nitroprussideEXELA PHARMANDA209387
NITROUS OXIDE, USPnitrous oxidePRAXAIR DISTRIBUTION INCNDA210235
NOCTIVAdesmopressin acetateACERUS PHARMSNDA201656
EPHEDRINE SULFATEephedrine sulfateRENEW PHARMSNDA208609
XERMELOtelotristat etiprateTERSERANDA208794
QTERNdapagliflozin, saxagliptin hydrochlorideASTRAZENECA ABNDA209091
GANZYK-RTUganciclovirEXELA PHARMANDA209347
SILIQbrodalumabVALEANT LUXEMBOURGBLA761032
EMFLAZAdeflazacortPTC THERAPNDA208684
EMFLAZAdeflazacortPTC THERAPNDA208685
PARSABIVetelcalcetideKAI PHARMS INCNDA208325
XYZAL ALLERGY 24HRlevocetirizine dihydrochlorideCHATTEM SANOFINDA209089
XYZAL ALLERGY 24HRlevocetirizine dihydrochlorideCHATTEM SANOFINDA209090
VYVANSElisdexamfetamine dimesylateTAKEDA PHARMS USANDA208510
AIRDUO DIGIHALERfluticasone propionate, salmeterol xinafoateTEVA PHARMNDA208799
ARMONAIR RESPICLICKfluticasone propionateTEVA PHARMNDA208798
CORPHEDRAephedrine sulfatePH HEALTHNDA208943
TEPADINA AND SODIUM CHLORIDEthiotepaADIENNE SANDA208264
TRULANCEplecanatideSALIXNDA208745
RHOFADEoxymetazoline hydrochlorideMAYNE PHARMANDA208552
VANTRELA ERhydrocodone bitartrateTEVA BRANDED PHARMNDA207975
ESBRIETpirfenidoneLEGACYNDA208780
ARYMO ERmorphine sulfateZYLANDA208603
NITROUS OXIDE, USPnitrous oxideMATHESON TRI-GAS INCNDA209989