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.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| ELZONRIS | tagraxofusp-erzs | STEMLINE THERAPEUTICS INC | BLA761116 | |
| INBRIJA | levodopa | MERZ | NDA209184 | |
| ULTOMIRIS | ravulizumab-cwvz | ALEXION PHARM | BLA761108 | |
| ASPARLAS | calaspargase pegol-mknl | SERVIER PHARMA LLC | BLA761102 | |
| ELEPSIA XR | levetiracetam | TRIPOINT | NDA204417 | |
| LICART | diclofenac epolamine | IBSA INST BIO | NDA206976 | |
| EZALLOR SPRINKLE | rosuvastatin calcium | SUN PHARM | NDA208647 | |
| HERZUMA | trastuzumab-pkrb | CELLTRION INC | BLA761091 | |
| MOTEGRITY | prucalopride succinate | TAKEDA PHARMS USA | NDA210166 | |
| TOLSURA | itraconazole | MAYNE PHARMA | NDA208901 | |
| DEXTENZA | dexamethasone | OCULAR THERAPEUTIX | NDA208742 | |
| FIRDAPSE | amifampridine phosphate | CATALYST PHARMS | NDA208078 | |
| TRUXIMA | rituximab-abbs | CELLTRION INC | BLA761088 | |
| XOSPATA | gilteritinib fumarate | ASTELLAS | NDA211349 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | EUGIA PHARMA SPECLTS | NDA209552 | |
| VITRAKVI | larotrectinib sulfate | BAYER HLTHCARE | NDA210861 | |
| VITRAKVI | larotrectinib sulfate | BAYER HEALTHCARE | NDA211710 | |
| DAURISMO | glasdegib maleate | PFIZER | NDA210656 | |
| SPY AGENT GREEN KIT | indocyanine green | NOVADAQ TECH | NDA211580 | |
| GAMIFANT | emapalumab-lzsg | NOVIMMUNE S.A. | BLA761107 | |
| READYPREP CHG | chlorhexidine gluconate | MEDLINE INDUSTRIES | NDA207964 | |
| AEMCOLO | rifamycin sodium | COSMO TECHNOLOGIES | NDA210910 | |
| TEMIXYS | lamivudine, tenofovir disoproxil fumarate | CHARTWELL RX | NDA211284 | |
| YUPELRI | revefenacin | MYLAN IRELAND LTD | NDA210598 | |
| PRIMATENE MIST | epinephrine | ARMSTRONG PHARMS | NDA205920 | |
| BRYHALI | halobetasol propionate | BAUSCH | NDA209355 | |
| DSUVIA | sufentanil citrate | VERTICAL PHARMS | NDA209128 | |
| LORBRENA | lorlatinib | PFIZER | NDA210868 | |
| UDENYCA | pegfilgrastim-cbqv | COHERUS BIOSCIENCES INC | BLA761039 | |
| SYMPAZAN | clobazam | COSETTE | NDA210833 | |
| HYRIMOZ | adalimumab-adaz | SANDOZ INC | BLA761071 | |
| CALCIUM GLUCONATE | calcium gluconate | HQ SPCLT PHARMA | NDA210906 | |
| BIJUVA | estradiol, progesterone | MAYNE PHARMA | NDA210132 | |
| XOFLUZA | baloxavir marboxil | GENENTECH INC | NDA210854 | |
| KHAPZORY | levoleucovorin | ACROTECH BIOPHARMA | NDA211226 | |
| QMIIZ ODT | meloxicam | TERSERA | NDA211210 | |
| HELIUM, USP | helium | MATHESON TRI-GAS INC | NDA212539 | |
| TALZENNA | talazoparib tosylate | PFIZER | NDA211651 | |
| YUTIQ | fluocinolone acetonide | ALIMERA SCIENCES INC | NDA210331 | |
| REVCOVI | elapegademase-lvlr | CHIESI USA INC | BLA761092 | |
| TEGSEDI | inotersen sodium | AKCEA THERAPS | NDA211172 | |
| NUZYRA | omadacycline tosylate | PARATEK PHARMS | NDA209816 | |
| NUZYRA | omadacycline tosylate | PARATEK PHARMS | NDA209817 | |
| SEYSARA | sarecycline hydrochloride | ALMIRALL | NDA209521 | |
| ARIKAYCE KIT | amikacin sulfate | INSMED INC | NDA207356 | |
| LIBTAYO | cemiplimab-rwlc | REGENERON PHARMACEUTICALS | BLA761097 | |
| XYOSTED (AUTOINJECTOR) | testosterone enanthate | ANTARES PHARMA INC | NDA209863 | |
| EMGALITY | galcanezumab-gnlm | ELI LILLY AND CO | BLA761063 | |
| VIZIMPRO | dacomitinib | PFIZER | NDA211288 | |
| COPIKTRA | duvelisib | SECURA | NDA211155 | |
| AJOVY | fremanezumab-vfrm | TEVA PHARMS USA | BLA761089 | |
| SEIZALAM | midazolam hydrochloride | MMT | NDA209566 | |
| LUMOXITI | moxetumomab pasudotox-tdfk | INNATE PHARMA | BLA761104 | |
| XELPROS | latanoprost | SUN PHARM | NDA206185 | |
| OXYGEN, USP | oxygen | CRISTAL ASU LLC | NDA211739 | |
| CASSIPA | buprenorphine hydrochloride, naloxone hydrochloride | TEVA PHARMS USA | NDA208042 | |
| TIGLUTIK KIT | riluzole | ITALFARMACO SA | NDA209080 | |
| DELSTRIGO | doravirine, lamivudine, tenofovir disoproxil fumarate | MSD MERCK CO | NDA210807 | |
| PIFELTRO | doravirine | MSD MERCK CO | NDA210806 | |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | leuprolide acetate | INVAGEN PHARMS | NDA205054 | |
| XERAVA | eravacycline dihydrochloride | TETRAPHASE PHARMS | NDA211109 | |
| NITROGEN, NF | nitrogen, nf | UNIVERSAL INDUSTRIAL GASES, INC | NDA212315 | |
| OXYGEN, USP | oxygen | UNIVERSAL INDUSTRIAL GASES, INC | NDA212314 | |
| ALTRENO | tretinoin | DOW PHARM | NDA209353 | |
| TAKHZYRO | lanadelumab-flyo | DYAX CORP. | BLA761090 | |
| INVELTYS | loteprednol etabonate | ALCON LABS INC | NDA210565 | |
| OXERVATE | cenegermin-bkbj | DOMPE FARMACEUTICI | BLA761094 | |
| DIACOMIT | stiripentol | BIOCODEX SA | NDA206709 | |
| DIACOMIT | stiripentol | BIOCODEX SA | NDA207223 | |
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz, lamivudine, tenofovir disoproxil fumarate | AUROBINDO PHARMA LTD | NDA022343 | |
| CEQUA | cyclosporine | SUN PHARM | NDA210913 | |
| LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE | lamivudine, nevirapine, zidovudine | MICRO LABS | NDA205626 | |
| ANNOVERA | ethinyl estradiol, segesterone acetate | MAYNE PHARMA | NDA209627 | |
| GALAFOLD | migalastat hydrochloride | AMICUS THERAP US | NDA208623 | |
| ONPATTRO | patisiran sodium | ALNYLAM PHARMS INC | NDA210922 | |
| ARAKODA | tafenoquine succinate | 60 DEGREES PHARMS | NDA210607 | |
| JORNAY PM | methylphenidate hydrochloride | IRONSHORE PHARMS | NDA209311 | |
| POTELIGEO | mogamulizumab-kpkc | KYOWA KIRIN | BLA761051 | |
| SOLUPREP S | chlorhexidine gluconate, isopropyl alcohol | SOLVENTUM | NDA208288 | |
| ORKAMBI | ivacaftor, lumacaftor | VERTEX PHARMS INC | NDA211358 | |
| TIGECYCLINE | tigecycline | AMNEAL | NDA211158 | |
| MULPLETA | lusutrombopag | VANCOCIN ITALIA | NDA210923 | |
| AZEDRA | iobenguane i-131 | PROGENICS PHARMS INC | NDA209607 | |
| REMODULIN | treprostinil | UNITED THERAP | NDA208276 | |
| OMEGAVEN | fish oil triglycerides | FRESENIUS KABI USA | NDA210589 | |
| PERSERIS KIT | risperidone | INDIVIOR | NDA210655 | |
| DOXERCALCIFEROL | doxercalciferol | HOSPIRA | NDA208614 | |
| ORILISSA | elagolix sodium | ABBVIE | NDA210450 | |
| KRINTAFEL | tafenoquine succinate | GLAXOSMITHKLINE | NDA210795 | |
| NIVESTYM | filgrastim-aafi | HOSPIRA INC | BLA761080 | |
| TIBSOVO | ivosidenib | SERVIER | NDA211192 | |
| SYMTUZA | cobicistat, darunavir, emtricitabine, tenofovir alafenamide fumarate | JANSSEN PRODS | NDA210455 | |
| INFUGEM | gemcitabine hydrochloride | SUN PHARM | NDA208313 | |
| TPOXX | tecovirimat | SIGA TECHNOLOGIES | NDA208627 | |
| GLYRX-PF | glycopyrrolate | EXELA PHARMA | NDA210997 | |
| VANCOMYCIN HYDROCHLORIDE | vancomycin hydrochloride | MYLAN LABS LTD | NDA209481 | |
| ATROPINE (AUTOINJECTOR) | atropine | RAFA LABS LTD | NDA212319 | |
| ARISTADA INITIO KIT | aripiprazole lauroxil | ALKERMES INC | NDA209830 | |
| NUPLAZID | pimavanserin tartrate | ACADIA PHARMS INC | NDA210793 | |
| QBREXZA | glycopyrronium tosylate | JOURNEY | NDA210361 | |
| BRAFTOVI | encorafenib | ARRAY BIOPHARMA INC | NDA210496 | |
| MEKTOVI | binimetinib | ARRAY BIOPHARMA INC | NDA210498 | |
| EPIDIOLEX | cannabidiol | JAZZ PHARMS RES | NDA210365 | |
| ZEMDRI | plazomicin sulfate | CIPLA USA | NDA210303 | |
| ABLYSINOL | dehydrated alcohol | BPI LABS | NDA207987 | |
| NOCDURNA | desmopressin acetate | FERRING PHARMS INC | NDA022517 | |
| LYMEPAK | doxycycline hyclate | CHARTWELL PHARMA | NDA209844 | |
| MOXIDECTIN | moxidectin | MDGH | NDA210867 | |
| FULPHILA | pegfilgrastim-jmdb | MYLAN GMBH | BLA761075 | |
| CONSENSI | amlodipine besylate, celecoxib | PURPLE BIOTECH | NDA210045 | |
| OLUMIANT | baricitinib | ELI LILLY AND CO | NDA207924 | |
| IMVEXXY | estradiol | MAYNE PHARMA | NDA208564 | |
| LEXETTE | halobetasol propionate | MAYNE PHARMA | NDA210566 | |
| PALYNZIQ | pegvaliase-pqpz | BIOMARIN PHARM | BLA761079 | |
| PROGRAF | tacrolimus | ASTELLAS | NDA210115 | |
| YONSA | abiraterone acetate | SUN PHARM | NDA210308 | |
| DOPTELET | avatrombopag maleate | AKARX INC | NDA210238 | |
| LOKELMA | sodium zirconium cyclosilicate | ASTRAZENECA | NDA207078 | |
| AIMOVIG | erenumab-aooe | AMGEN INC | BLA761077 | |
| LUCEMYRA | lofexidine hydrochloride | BIOCORRX PHARMS | NDA209229 | |
| BELRAPZO | bendamustine hydrochloride | EAGLE PHARMS | NDA205580 | |
| LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | lamivudine, tenofovir disoproxil fumarate | AUROBINDO PHARMA LTD | NDA022344 | |
| RETACRIT | epoetin alfa-epbx | HOSPIRA INC | BLA125545 | |
| PLENVU | ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, sodium sulfate | NORGINE | NDA209381 | |
| XTRELUS | guaifenesin, hydrocodone bitartrate | ECI PHARMS LLC | NDA208085 | |
| HELIUM, USP | helium | A-OX WELDING SUPPLY CO, INC. | NDA211781 | |
| JYNARQUE | tolvaptan | OTSUKA | NDA204441 | |
| AKYNZEO | fosnetupitant chloride hydrochloride, palonosetron hydrochloride | HELSINN HLTHCARE | NDA210493 | |
| CRYSVITA | burosumab-twza | KYOWA KIRIN | BLA761068 | |
| TAVALISSE | fostamatinib disodium | RIGEL PHARMS | NDA209299 | |
| NITROGEN, NF | nitrogen | CRISTAL ASU LLC | NDA211737 | |
| SYMFI | efavirenz, lamivudine, tenofovir disoproxil fumarate | MYLAN LABS LTD | NDA022142 | |
| ILUMYA | tildrakizumab-asmn | SUN PHARMA GLOBAL | BLA761067 | |
| TROGARZO | ibalizumab-uiyk | THERATECHNOLOGIES | BLA761065 | |
| CIMDUO | lamivudine, tenofovir disoproxil fumarate | MYLAN LABS LTD | NDA022141 | |
| ZTLIDO | lidocaine | SCILEX PHARMS | NDA207962 | |
| VERZENIO | abemaciclib | ELI LILLY AND CO | NDA208855 | |
| APADAZ | acetaminophen, benzhydrocodone hydrochloride | ZEVRA THERAP | NDA208653 | |
| IMBRUVICA | ibrutinib | PHARMACYCLICS LLC | NDA210563 | |
| OSMOLEX ER | amantadine hydrochloride | SUPERNUS PHARMS | NDA209410 | |
| ERLEADA | apalutamide | JANSSEN BIOTECH | NDA210951 | |
| SYMDEKO (COPACKAGED) | ivacaftor, ivacaftor, tezacaftor | VERTEX PHARMS INC | NDA210491 | |
| DEXYCU KIT | dexamethasone | EYEPOINT PHARMS | NDA208912 | |
| RADIOGENIX SYSTEM | technetium tc-99m sodium pertechnetate generator | NORTHSTAR MEDICAL | NDA202158 | |
| BIKTARVY | bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA210251 | |
| SYMFI LO | efavirenz, lamivudine, tenofovir disoproxil fumarate | MYLAN | NDA208255 | |
| ATROPINE SULFATE | atropine sulfate | FRESENIUS KABI USA | NDA209260 | |
| FIRVANQ KIT | vancomycin hydrochloride | AZURITY | NDA208910 | |
| KAPSPARGO SPRINKLE | metoprolol succinate | SPIL | NDA210428 | |
| LUTATHERA | lutetium lu 177 dotatate | AAA USA INC | NDA208700 | |
| TIGECYCLINE | tigecycline | ACCORD HLTHCARE INC | NDA208744 | |
| BALCOLTRA | ethinyl estradiol, levonorgestrel | AVION PHARMS | NDA208612 |