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.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| UBRELVY | ubrogepant | ABBVIE | NDA211765 | |
| CAPLYTA | lumateperone tosylate | INTRA-CELLULAR | NDA209500 | |
| DAYVIGO | lemborexant | EISAI INC | NDA212028 | |
| ENHERTU | fam-trastuzumab deruxtecan-nxki | DAIICHI SANKYO | BLA761139 | |
| GENOSYL | nitric oxide | VERO BIOTECH INC | NDA202860 | |
| TISSUEBLUE | brilliant blue g | DUTCH OPHTHALMIC | NDA209569 | |
| CONJUPRI | levamlodipine maleate | CSPC OUYI | NDA212895 | |
| ARAZLO | tazarotene | BAUSCH | NDA211882 | |
| PADCEV | enfortumab vedotin-ejfv | ASTELLAS | BLA761137 | |
| NOURESS | cysteine hydrochloride | BAXTER HLTHCARE CORP | NDA212535 | |
| VYONDYS 53 | golodirsen | SAREPTA THERAPS INC | NDA211970 | |
| AVSOLA | infliximab-axxq | AMGEN INC | BLA761086 | |
| REDITREX | methotrexate | NORDIC GRP | NDA210737 | |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic, potassium phosphate, monobasic | FRESENIUS KABI USA | NDA212832 | |
| OXBRYTA | voxelotor | GLOBAL BLOOD THERAPS | NDA213137 | |
| EXSERVAN | riluzole | AQUESTIVE | NDA212640 | |
| XCOPRI | cenobamate | SK LIFE | NDA212839 | |
| GIVLAARI | givosiran sodium | ALNYLAM PHARMS INC | NDA212194 | |
| ABRILADA | adalimumab-afzb | PFIZER INC | BLA761118 | |
| ADAKVEO | crizanlizumab-tmca | NOVARTIS PHARMS CORP | BLA761128 | |
| BRUKINSA | zanubrutinib | BEONE MEDICINES USA | NDA213217 | |
| FETROJA | cefiderocol sulfate tosylate | SHIONOGI | NDA209445 | |
| REBLOZYL | luspatercept-aamt | CELGENE CORP | BLA761136 | |
| EXEM FOAM KIT | air polymer-type a | GISKIT | NDA212279 | |
| ABSORICA LD | isotretinoin | SUN PHARM | NDA211913 | |
| EPINEPHRINE | epinephrine | HOSPIRA | NDA209359 | |
| ZIEXTENZO | pegfilgrastim-bmez | SANDOZ INC | BLA761045 | |
| IBRANCE | palbociclib | PFIZER | NDA212436 | |
| TALICIA | amoxicillin, omeprazole magnesium, rifabutin | TALICIA HOLDINGS | NDA213004 | |
| VUMERITY | diroximel fumarate | BIOGEN | NDA211855 | |
| HELIUM, USP | helium | ILMO Products Company | NDA213990 | |
| BIORPHEN | phenylephrine hydrochloride | DR REDDYS LABS SA | NDA212909 | |
| TRIKAFTA (COPACKAGED) | elexacaftor, ivacaftor, tezacaftor, ivacaftor | VERTEX PHARMS INC | NDA212273 | |
| AMZEEQ | minocycline hydrochloride | JOURNEY | NDA212379 | |
| REYVOW | lasmiditan succinate | ELI LILLY AND CO | NDA211280 | |
| SECUADO | asenapine | HISAMITSU | NDA212268 | |
| FLUORODOPA F18 | fluorodopa f-18 | FEINSTEIN | NDA200655 | |
| SCENESSE | afamelanotide | CLIVUNEL INC | NDA210797 | |
| BEOVU | brolucizumab-dbll | NOVARTIS PHARMS CORP | BLA761125 | |
| AKLIEF | trifarotene | GALDERMA LABS LP | NDA211527 | |
| BONSITY | teriparatide | ALVOGEN | NDA211939 | |
| BORTEZOMIB | bortezomib | DR REDDYS | NDA206927 | |
| QUZYTTIR | cetirizine hydrochloride | ESTEVE | NDA211415 | |
| HEMADY | dexamethasone | DEXCEL | NDA211379 | |
| OZEMPIC | semaglutide | NOVO | NDA213051 | |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic, potassium phosphate, monobasic | CMP DEV LLC | NDA212121 | |
| OZOBAX DS | baclofen | METACEL PHARMS LLC | NDA208193 | |
| IBSRELA | tenapanor hydrochloride | ARDELYX INC | NDA211801 | |
| GVOKE KIT | glucagon | XERIS | NDA212097 | |
| FOSAPREPITANT DIMEGLUMINE | fosaprepitant dimeglumine | TEVA PHARMS USA | NDA210064 | |
| RIOMET ER | metformin hydrochloride | SUN PHARM | NDA212595 | |
| HARVONI | ledipasvir, sofosbuvir | GILEAD SCIENCES INC | NDA212477 | |
| SOVALDI | sofosbuvir | GILEAD SCIENCES INC | NDA212480 | |
| NOURIANZ | istradefylline | KYOWA KIRIN | NDA022075 | |
| GALLIUM GA 68 EDOTREOTIDE | gallium ga-68 edotreotide | UIHC PET IMAGING | NDA210828 | |
| CLIGAVYX | fulvestrant | AVYXA HOLDINGS | NDA210063 | |
| XENLETA | lefamulin acetate | HONG KONG | NDA211672 | |
| XENLETA | lefamulin acetate | HONG KONG | NDA211673 | |
| HELIUM, USP | helium | A G L WELDING SUPPLY CO INC | NDA213727 | |
| INREBIC | fedratinib hydrochloride | BRISTOL-MYERS | NDA212327 | |
| RINVOQ | upadacitinib | ABBVIE | NDA211675 | |
| ROZLYTREK | entrectinib | GENENTECH INC | NDA212725 | |
| ROZLYTREK | entrectinib | GENENTECH INC | NDA212726 | |
| PRETOMANID | pretomanid | MYLAN IRELAND LTD | NDA212862 | |
| WAKIX | pitolisant hydrochloride | HARMONY | NDA211150 | |
| TURALIO | pexidartinib hydrochloride | DAIICHI SANKYO INC | NDA211810 | |
| NUBEQA | darolutamide | BAYER HEALTHCARE | NDA212099 | |
| ACCRUFER | ferric maltol | SHIELD TX | NDA212320 | |
| ANGIOMAX RTU | bivalirudin | MAIA PHARMS INC | NDA211215 | |
| BAQSIMI | glucagon | AMPHASTAR PHARMS INC | NDA210134 | |
| HADLIMA | adalimumab-bwwd | SAMSUNG BIOEPIS CO LTD | BLA761059 | |
| RUXIENCE | rituximab-pvvr | PFIZER INC | BLA761103 | |
| DRIZALMA SPRINKLE | duloxetine hydrochloride | SUN PHARM | NDA212516 | |
| ZINC SULFATE | zinc sulfate | AM REGENT | NDA209377 | |
| RECARBRIO | cilastatin sodium, imipenem, relebactam | MSD MERCK CO | NDA212819 | |
| HELIUM, USP | helium | ROBERTS OXYGEN CO INC | NDA213609 | |
| KATERZIA | amlodipine benzoate | AZURITY | NDA211340 | |
| XPOVIO | selinexor | KARYOPHARM THERAPS | NDA212306 | |
| THIOLA EC | tiopronin | MISSION PHARMACAL | NDA211843 | |
| ZIRABEV | bevacizumab-bvzr | PFIZER INC | BLA761099 | |
| VYLEESI (AUTOINJECTOR) | bremelanotide acetate | COSETTE | NDA210557 | |
| MYXREDLIN | insulin human | BAXTER HLTHCARE CORP | BLA208157 | |
| CARBON DIOXIDE, USP | carbon dioxide | A-OX WELDING SUPPLY CO, INC. | NDA213507 | |
| KANJINTI | trastuzumab-anns | AMGEN INC | BLA761073 | |
| ORTIKOS | budesonide | SUN PHARM INDS INC | NDA211929 | |
| POLIVY | polatuzumab vedotin-piiq | GENENTECH | BLA761121 | |
| NUCALA | mepolizumab | GLAXOSMITHKLINE | BLA761122 | |
| PIQRAY | alpelisib | NOVARTIS | NDA212526 | |
| SLYND | drospirenone | EXELTIS USA INC | NDA211367 | |
| FULVESTRANT | fulvestrant | FRESENIUS KABI USA | NDA210326 | |
| NAYZILAM | midazolam | UCB INC | NDA211321 | |
| VYNDAMAX | tafamidis | FOLDRX PHARMS | NDA212161 | |
| VYNDAQEL | tafamidis meglumine | FOLDRX PHARMS | NDA211996 | |
| QTERNMET XR | dapagliflozin, metformin hydrochloride, saxagliptin hydrochloride | ASTRAZENECA AB | NDA210874 | |
| SELENIOUS ACID | selenious acid | AM REGENT | NDA209379 | |
| ZURAGARD | isopropyl alcohol | ZUREX PHARMA | NDA210872 | |
| DUOBRII | halobetasol propionate, tazarotene | BAUSCH | NDA209354 | |
| ETICOVO | etanercept-ykro | SAMSUNG BIOEPIS CO LTD | BLA761066 | |
| SKYRIZI | risankizumab-rzaa | ABBVIE INC | BLA761105 | |
| CORLANOR | ivabradine | AMGEN INC | NDA209964 | |
| ELCYS | cysteine hydrochloride | EXELA PHARMA | NDA210660 | |
| TRANEXAMIC ACID | tranexamic acid | EXELA PHARMA | NDA212020 | |
| BALVERSA | erdafitinib | JANSSEN BIOTECH | NDA212018 | |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | FRESENIUS KABI USA | NDA210632 | |
| EVENITY | romosozumab-aqqg | AMGEN INC | BLA761062 | |
| DOVATO | dolutegravir sodium, lamivudine | VIIV HLTHCARE | NDA211994 | |
| WELCHOL | colesevelam hydrochloride | COSETTE | NDA210895 | |
| AVACLYR | acyclovir | FERA PHARMS LLC | NDA202408 | |
| DUAKLIR PRESSAIR | aclidinium bromide, formoterol fumarate | AZURITY | NDA210595 | |
| MAVENCLAD | cladribine | EMD SERONO INC | NDA022561 | |
| JATENZO | testosterone undecanoate | TOLMAR | NDA206089 | |
| MAYZENT | siponimod | NOVARTIS | NDA209884 | |
| SUNOSI | solriamfetol hydrochloride | AXSOME MALTA | NDA211230 | |
| ZULRESSO | brexanolone | SAGE THERAP SUPERNUS | NDA211371 | |
| ZYKADIA | ceritinib | NOVARTIS | NDA211225 | |
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz, lamivudine, tenofovir disoproxil fumarate | MACLEODS PHARMS | NDA210649 | |
| ROCKLATAN | latanoprost, netarsudil dimesylate | ALCON LABS INC | NDA208259 | |
| TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | BAUSCH LOMB IRELAND | NDA210821 | |
| TRAZIMERA | trastuzumab-qyyp | PFIZER INC | BLA761081 | |
| SPRAVATO | esketamine hydrochloride | JANSSEN PHARMS | NDA211243 | |
| HERCEPTIN HYLECTA | trastuzumab and hyaluronidase-oysk | GENENTECH INC | BLA761106 | |
| ADHANSIA XR | methylphenidate hydrochloride | KNOA PHARMA | NDA212038 | |
| LOTEMAX SM | loteprednol etabonate | BAUSCH AND LOMB INC | NDA208219 | |
| TYZAVAN | vancomycin hydrochloride | HIKMA | NDA211962 | |
| EGATEN | triclabendazole | NOVARTIS | NDA208711 | |
| CABLIVI | caplacizumab-yhdp | ABLYNX NV | BLA761112 | |
| JEUVEAU | prabotulinumtoxina-xvfs | EVOLUS INC | BLA761085 | |
| EVEKEO ODT | amphetamine sulfate | AZURITY | NDA209905 | |
| GLOPERBA | colchicine | SCILEX PHARMS | NDA210942 | |
| TOSYMRA | sumatriptan | TONIX MEDS | NDA210884 | |
| ONTRUZANT | trastuzumab-dttb | SAMSUNG BIOEPIS CO LTD | BLA761100 |