All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2020
FDA approved the original submission of 129 new drug and biologics license applications in 2020, from 108 sponsors. FDA marks 15 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| GEMTESA | vibegron | SUMITOMO PHARMA AM | NDA213006 | |
| EBANGA | ansuvimab-zykl | RIDGEBACK BIOTHERAPEUTICS | BLA761172 | |
| ORGOVYX | relugolix | SUMITOMO PHARMA AM | NDA214621 | |
| RIABNI | rituximab-arrx | AMGEN INC | BLA761140 | |
| MARGENZA | margetuximab-cmkb | MACROGENICS INC | BLA761150 | |
| KLISYRI | tirbanibulin | ALMIRALL | NDA213189 | |
| ORLADEYO | berotralstat dihydrochloride | BIOCRYST | NDA214094 | |
| GALLIUM GA 68 GOZETOTIDE | gallium ga-68 gozetotide | UNIV CA LOS ANGELES | NDA212642 | |
| GALLIUM GA 68 GOZETOTIDE | gallium ga-68 gozetotide | UNIV OF CA SAN FRAN | NDA212643 | |
| GAVRETO | pralsetinib | BLUEPRINT MEDICINES | NDA214701 | |
| HETLIOZ LQ | tasimelteon | VANDA PHARMS INC | NDA214517 | |
| THYQUIDITY | levothyroxine sodium | STEVENS J | NDA214047 | |
| DANYELZA | naxitamab-gqgk | Y-MABS THERAPEUTICS INC | BLA761171 | |
| IMCIVREE | setmelanotide acetate | RHYTHM | NDA213793 | |
| OXLUMO | lumasiran sodium | ALNYLAM PHARMS INC | NDA214103 | |
| XOFLUZA | baloxavir marboxil | GENENTECH INC | NDA214410 | |
| ZOKINVY | lonafarnib | SENTYNL THERAPS INC | NDA213969 | |
| SUTAB | magnesium sulfate, potassium chloride, sodium sulfate | AZURITY | NDA213135 | |
| LABETALOL HYDROCHLORIDE | labetalol hydrochloride | HIKMA | NDA213330 | |
| SESQUIENT | fosphenytoin sodium | LUPIN | NDA210864 | |
| BRONCHITOL | mannitol | PHARMAXIS EUROPE | NDA202049 | |
| EYSUVIS | loteprednol etabonate | ALCON LABS INC | NDA210933 | |
| VEKLURY | remdesivir | GILEAD SCIENCES INC | NDA214787 | |
| ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | DEXCEL | NDA214278 | |
| EPHEDRINE SULFATE | ephedrine sulfate | PH HEALTH | NDA213994 | |
| INMAZEB | atoltivimab, odesivimab, maftivimab | REGENERON PHARMACEUTICALS | BLA761169 | |
| ALKINDI SPRINKLE | hydrocortisone | ETON | NDA213876 | |
| ATROPINE SULFATE | atropine sulfate | ACCORD HLTHCARE | NDA214652 | |
| XELJANZ | tofacitinib citrate | PFIZER | NDA213082 | |
| GAVRETO | pralsetinib | RIGEL PHARMS | NDA213721 | |
| DETECTNET | copper cu-64 dotatate | CURIUM | NDA213227 | |
| ONUREG | azacitidine | BRISTOL | NDA214120 | |
| QDOLO | tramadol hydrochloride | ROSEMOUNT | NDA214044 | |
| SOGROYA | somapacitan-beco | NOVO NORDISK INC | BLA761156 | |
| XARACOLL | bupivacaine hydrochloride | INNOCOLL PHARMS | NDA209511 | |
| WINLEVI | clascoterone | SUN PHARM | NDA213433 | |
| METHOTREXATE | methotrexate | ACCORD HLTHCARE | NDA214121 | |
| PEMETREXED | pemetrexed | ACTAVIS | NDA208419 | |
| CYSTADROPS | cysteamine hydrochloride | RECORDATI RARE | NDA211302 | |
| ENSPRYNG | satralizumab | GENENTECH | BLA761149 | |
| VILTEPSO | viltolarsen | NIPPON SHINYAKU | NDA212154 | |
| EVRYSDI | risdiplam | GENENTECH INC | NDA213535 | |
| OLINVYK | oliceridine | TREVENA | NDA210730 | |
| LAMPIT | nifurtimox | BAYER HEALTHCARE | NDA213464 | |
| XTANDI | enzalutamide | ASTELLAS | NDA213674 | |
| VASOPRESSIN | vasopressin | AM REGENT | NDA212593 | |
| MONJUVI | tafasitamab-cxix | MORPHOSYS US INC | BLA761163 | |
| CYCLOPHOSPHAMIDE | cyclophosphamide | DR REDDYS | NDA212501 | |
| XEGLYZE | abametapir | LNHC | NDA206966 | |
| BREZTRI AEROSPHERE | budesonide, formoterol fumarate, glycopyrrolate | ASTRAZENECA AB | NDA212122 | |
| XYWAV | calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate | JAZZ | NDA212690 | |
| WYNZORA | betamethasone dipropionate, calcipotriene | MC2 | NDA213422 | |
| CARBON DIOXIDE, USP | carbon dioide | NEXAIR LLC | NDA215007 | |
| UPNEEQ | oxymetazoline hydrochloride | RVL PHARMS | NDA212520 | |
| INQOVI | cedazuridine, decitabine | TAIHO ONCOLOGY | NDA212576 | |
| HULIO | adalimumab-fkjp | MYLAN PHARMS INC | BLA761154 | |
| QWO | collagenase clostridium histolyticum-aaes | ENDO GLOBAL AESTHETICS LTD | BLA761146 | |
| BYFAVO | remimazolam besylate | ACACIA | NDA212295 | |
| MULTRYS | cupric sulfate, manganese sulfate, selenious acid, zinc sulfate | AM REGENT | NDA209376 | |
| RUKOBIA | fostemsavir tromethamine | VIIV HLTHCARE | NDA212950 | |
| DOJOLVI | triheptanoin | ULTRAGENYX PHARM INC | NDA213687 | |
| Nitrogen, NF | nitrogen | AIR LIQUIDE CANADA INC | NDA214858 | |
| PHESGO | pertuzumab, trastuzumab, and hyaluronidase-zzxf | GENENTECH INC | BLA761170 | |
| HELIUM, USP | helium | WESTAIR GASES & EQUIPMENT INC | NDA214937 | |
| MYCAPSSA | octreotide acetate | CHIESI | NDA208232 | |
| FINTEPLA | fenfluramine hydrochloride | UCB INC | NDA212102 | |
| GIMOTI | metoclopramide hydrochloride | QOL MEDCL | NDA209388 | |
| TAZVERIK | tazemetostat hydrobromide | EPIZYME INC | NDA213400 | |
| LYUMJEV | insulin lispro-aabc | ELI LILLY AND CO | BLA761109 | |
| ZEPZELCA | lurbinectedin | JAZZ | NDA213702 | |
| TIVICAY PD | dolutegravir sodium | VIIV HLTHCARE | NDA213983 | |
| SEMGLEE | insulin glargine | MYLAN PHARMS INC | BLA210605 | |
| UPLIZNA | inebilizumab-cdon | VIELA BIO | BLA761142 | |
| NYVEPRIA | pegfilgrastim-apgf | HOSPIRA INC | BLA761111 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE CANADA INC | NDA214857 | |
| ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate, elagolix sodium | ABBVIE | NDA213388 | |
| TAUVID | flortaucipir f-18 | AVID RADIOPHARMS INC | NDA212123 | |
| ZILXI | minocycline hydrochloride | JOURNEY | NDA213690 | |
| ARTESUNATE | artesunate | AMIVAS | NDA213036 | |
| VESICARE LS | solifenacin succinate | ASTELLAS | NDA209529 | |
| PHEXX | citric acid, lactic acid, potassium bitartrate | EVOFEM INC | NDA208352 | |
| KYNMOBI | apomorphine hydrochloride | SUMITOMO PHARMA AM | NDA210875 | |
| CERIANNA | fluoroestradiol f-18 | GE HEALTHCARE | NDA212155 | |
| FERRIPROX | deferiprone | CHIESI | NDA212269 | |
| IMPEKLO | clobetasol propionate | PHARMOBEDIENT | NDA213691 | |
| QINLOCK | ripretinib | DECIPHERA PHARMS | NDA213973 | |
| RETEVMO | selpercatinib | ELI LILLY AND CO | NDA213246 | |
| TABRECTA | capmatinib hydrochloride | NOVARTIS PHARM | NDA213591 | |
| ELYXYB | celecoxib | SCILEX PHARMS | NDA212157 | |
| DARZALEX FASPRO | daratumumab and hyaluronidase-fihj | JANSSEN BIOTECH | BLA761145 | |
| FENSOLVI KIT | leuprolide acetate | TOLMAR | NDA213150 | |
| MILPROSA | progesterone | FERRING PHARMS INC | NDA201110 | |
| BAFIERTAM | monomethyl fumarate | BANNER LIFE SCIENCES | NDA210296 | |
| ONGENTYS | opicapone | AMNEAL | NDA212489 | |
| TRODELVY | sacituzumab govitecan-hziy | IMMUNOMEDICS INC | BLA761115 | |
| EMERPHED | ephedrine sulfate | NEXUS | NDA213407 | |
| PEMAZYRE | pemigatinib | INCYTE CORP | NDA213736 | |
| TUKYSA | tucatinib | SEAGEN | NDA213411 | |
| JELMYTO | mitomycin | UROGEN PHARMA | NDA211728 | |
| KOSELUGO | selumetinib sulfate | ASTRAZENECA | NDA213756 | |
| TYBLUME | ethinyl estradiol, levonorgestrel | EXELTIS USA INC | NDA209405 | |
| TRIFERIC AVNU | ferric pyrophosphate citrate | ROCKWELL MEDICAL INC | NDA212860 | |
| ZEPOSIA | ozanimod hydrochloride | BRISTOL | NDA209899 | |
| PULMOTECH MAA | technetium tc99m albumin aggregated | CIS BIO INTL | BLA210089 | |
| ROMIDEPSIN | romidepsin | TEVA PHARMS USA INC | NDA208574 | |
| FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE | benoxinate hydrochloride, fluorescein sodium | BAUSCH LOMB IRELAND | NDA211039 | |
| ISTURISA | osilodrostat phosphate | RECORDATI RARE | NDA212801 | |
| DURYSTA | bimatoprost | ABBVIE | NDA211911 | |
| SARCLISA | isatuximab-irfc | SANOFI AVENTIS US | BLA761113 | |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen, ibuprofen | HALEON US HOLDINGS | NDA211733 | |
| NURTEC ODT | rimegepant sulfate | PFIZER | NDA212728 | |
| BARHEMSYS | amisulpride | LXO IRELAND | NDA209510 | |
| NEXLIZET | bempedoic acid, ezetimibe | ESPERION THERAPS INC | NDA211617 | |
| NEXLETOL | bempedoic acid | ESPERION THERAPS INC | NDA211616 | |
| VYEPTI | eptinezumab-jjmr | Lundbeck Seattle BioPharmaceuticals, Inc. | BLA761119 | |
| ANJESO | meloxicam | BAUDAX | NDA210583 | |
| PROCYSBI | cysteamine bitartrate | HORIZON | NDA213491 | |
| TWIRLA | ethinyl estradiol, levonorgestrel | AGILE | NDA204017 | |
| PIZENSY | lactitol | BRAINTREE LABS | NDA211281 | |
| PEMFEXY | pemetrexed | EAGLE PHARMS | NDA209472 | |
| TRIJARDY XR | empagliflozin, linagliptin, metformin hydrochloride | BOEHRINGER INGELHEIM | NDA212614 | |
| DIFICID | fidaxomicin | CUBIST PHARMS LLC | NDA213138 | |
| TAZVERIK | tazemetostat hydrobromide | EPIZYME INC | NDA211723 | |
| TEPEZZA | teprotumumab-trbw | HORIZON THERAPEUTICS IRELAND | BLA761143 | |
| MONOFERRIC | ferric derisomaltose | PHARMACOSMOS | NDA208171 | |
| RYBELSUS | semaglutide | NOVO NORDISK INC | NDA213182 | |
| NUMBRINO | cocaine hydrochloride | OMNIVIUM PHARMS | NDA209575 | |
| VALTOCO | diazepam | NEURELIS INC | NDA211635 | |
| AYVAKIT | avapritinib | BLUEPRINT MEDICINES | NDA212608 |