All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2016

FDA approved the original submission of 100 new drug and biologics license applications in 2016, from 79 sponsors. FDA marks 21 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
CASPOFUNGIN ACETATEcaspofungin acetateFRESENIUS KABI USANDA206110
COLPREP KITmagnesium sulfate, potassium sulfate, sodium sulfateGATOR PHARMSNDA204553
MEDICAL AIR, USPmedical airGENERAL SERVICES & SUPPLY CONDA209927
SPINRAZAnusinersen sodiumBIOGENNDA209531
RUBRACArucaparib camsylatePHARMAANDNDA209115
TIROSINT-SOLlevothyroxine sodiumIBSANDA206977
EUCRISAcrisaboroleANACOR PHARMS INCNDA207695
SYNJARDY XRempagliflozin, metformin hydrochlorideBOEHRINGER INGELHEIMNDA208658
ISOPTO ATROPINEatropine sulfateALCON LABS INCNDA208151
TIGECYCLINEtigecyclineFRESENIUS KABI USANDA205645
SOLIQUA 100/33insulin glargine, lixisenatideSANOFI-AVENTIS USBLA208673
XULTOPHY 100/3.6insulin degludec, liraglutideNOVOBLA208583
INTRAROSAprasteroneMILLICENTNDA208470
VEMLIDYtenofovir alafenamide fumarateGILEAD SCIENCES INCNDA208464
BONJESTAdoxylamine succinate, pyridoxine hydrochlorideDUCHESNAYNDA209661
SELZENTRYmaravirocVIIV HLTHCARENDA208984
ZINPLAVAbezlotoxumabMERCK SHARP DOHMEBLA761046
EVZIO (AUTOINJECTOR)naloxone hydrochlorideKALEO INCNDA209862
LARTRUVOolaratumabELI LILLY AND COBLA761038
VERMOXmebendazoleJANSSEN PHARMSNDA208398
TECENTRIQatezolizumabGENENTECH INCBLA761041
VARIBAR PUDDINGbarium sulfateBRACCONDA208844
CARNEXIVcarbamazepineLUNDBECK PHARMS LLCNDA206030
RUBY-FILLrubidium chloride rb-82JUBILANTNDA202153
LEVOLEUCOVORIN CALCIUMlevoleucovorin calciumACTAVIS LLCNDA208723
AMJEVITAadalimumab-attoAMGEN INCBLA761024
STELARAustekinumabJANSSEN BIOTECHBLA761044
EPANEDenalapril maleateAZURITYNDA208686
INVOKAMET XRcanagliflozin, metformin hydrochlorideJANSSEN PHARMSNDA205879
EXONDYS 51eteplirsenSAREPTA THERAPS INCNDA206488
KYLEENAlevonorgestrelBAYER HLTHCARENDA208224
YOSPRALAaspirin, omeprazoleGENUS LIFESCIENCESNDA205103
ERELZIetanercept-szzsSANDOZBLA761042
PALONOSETRON HYDROCHLORIDEpalonosetron hydrochlorideHIKMANDA207963
TROXYCA ERnaltrexone hydrochloride, oxycodone hydrochloridePFIZERNDA207621
SUSTOLgranisetronHERON THERAPS INCNDA022445
QBRELISlisinoprilAZURITYNDA208401
ADLYXINlixisenatideSANOFI-AVENTIS USBLA208471
VIEKIRA XRdasabuvir sodium, ombitasvir, paritaprevir, ritonavirABBVIENDA208624
RELISTORmethylnaltrexone bromideSALIXNDA208271
SMOFLIPID 20%fish oil, medium chain triglycerides, olive oil, soybean oilFRESENIUS KABI USANDA207648
XIIDRAlifitegrastBAUSCH AND LOMB INCNDA208073
SYNDROSdronabinolWELLHOUSE PHARMANDA205525
KOVANAZEoxymetazoline hydrochloride, tetracaine hydrochlorideST RENATUSNDA208032
EPCLUSAsofosbuvir, velpatasvirGILEAD SCIENCES INCNDA208341
RAYALDEEcalcifediolEIRGENNDA208010
GONITROnitroglycerinPOHL BOSKAMPNDA208424
LANSOPRAZOLElansoprazoleDEXCELNDA208025
BYVALSONnebivolol hydrochloride, valsartanABBVIENDA206302
NETSPOTgallium dotatate ga-68NOVARTISNDA208547
AXUMINfluciclovine f-18BLUE EARTHNDA208054
JENTADUETO XRlinagliptin, metformin hydrochlorideBOEHRINGER INGELHEIMNDA208026
OCALIVAobeticholic acidINTERCEPTNDA207999
ZINBRYTAdaclizumabBIOGENBLA761029
PROBUPHINEbuprenorphine hydrochlorideREACX PHARMSNDA204442
TECENTRIQatezolizumabGENENTECH INCBLA761034
AMELUZaminolevulinic acid hydrochlorideBIOFRONTERANDA208081
AKOVAZephedrine sulfateEXELA PHARMANDA208289
AZACITIDINEazacitidineACTAVIS LLCNDA208216
FYCOMPAperampanelCATALYST PHARMSNDA208277
NUPLAZIDpimavanserin tartrateACADIA PHARMS INCNDA207318
OTOVELciprofloxacin hydrochloride, fluocinolone acetonideLAB SALVATNDA208251
ACTICLATE CAPdoxycycline hyclateCHARTWELL RXNDA208253
XTAMPZA ERoxycodoneCOLLEGIUM PHARM INCNDA208090
BEVESPI AEROSPHEREformoterol fumarate, glycopyrrolateASTRAZENECANDA208294
CABOMETYXcabozantinib s-malateEXELIXIS INCNDA208692
TRIFERICferric pyrophosphate citrateROCKWELL MEDICAL INCNDA208551
ORFADINnitisinoneSWEDISH ORPHANNDA206356
FLOLIPIDsimvastatinSALERNO PHARMSNDA206679
PHOTREXA VISCOUS IN DEXTRAN 20%riboflavin 5'-phosphate, riboflavin 5'-phosphate sodiumGLAUKOSNDA203324
VENCLEXTAvenetoclaxABBVIENDA208573
BROMSITEbromfenac sodiumSUN PHARMNDA206911
PROVAYBLUEmethylene bluePROVEPHARM SASNDA204630
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINEResmolol hydrochlorideHQ SPCLT PHARMANDA205703
INFLECTRAinfliximab-dyybCELLTRION INCBLA125544
DESCOVYemtricitabine, tenofovir alafenamide fumarateGILEAD SCIENCES INCNDA208215
DEFITELIOdefibrotide sodiumJAZZ PHARMS INCNDA208114
CINQAIRreslizumabTEVA RESPIRATORY LLCBLA761033
TALTZixekizumabELI LILLY AND COBLA125521
ANTHIMobiltoxaximabELUSYS THERAPEUTICS INCBLA125509
EVOMELAmelphalan hydrochlorideACROTECH BIOPHARMANDA207155
ODEFSEYemtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarateGILEAD SCIENCES INCNDA208351
POSFREApalonosetron hydrochlorideAVYXA HOLDINGSNDA203050
TETRACAINE HYDROCHLORIDEtetracaine hydrochlorideALCON LABSNDA208135
ACZONEdapsoneALMIRALLNDA207154
XELJANZ XRtofacitinib citratePFIZERNDA208246
HELIUM, USPheliumNEXAIR LLCNDA209033
BRIVIACTbrivaracetamUCB INCNDA205836
BRIVIACTbrivaracetamUCB INCNDA205837
BRIVIACTbrivaracetamUCB INCNDA205838
SERNIVObetamethasone dipropionatePRIMUS PHARMSNDA208079
PARICALCITOLparicalcitolACCORD HLTHCARENDA207174
CETYLEVacetylcysteineARBOR PHARMS LLCNDA207916
ZEMBRACE SYMTOUCHsumatriptan succinateTONIX MEDSNDA208223
ZEPATIERelbasvir, grazoprevirMSD SUB MERCKNDA208261
ADZENYS XR-ODTamphetamineNEOS THERAPSNDA204326
ONZETRA XSAILsumatriptan succinateAZURITYNDA206099
DEXILANT SOLUTABdexlansoprazoleTAKEDA PHARMS USANDA208056
VARIBAR HONEYbarium sulfateBRACCONDA208143
E-Z-CAT DRYbarium sulfateBRACCONDA208036