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.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| LUMIFY | brimonidine tartrate | BAUSCH AND LOMB INC | NDA208144 | |
| BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | bivalirudin | BAXTER HLTHCARE CORP | NDA208374 | |
| GIAPREZA | angiotensin ii acetate | LA JOLLA PHARMA | NDA209360 | |
| SIKLOS | hydroxyurea | THERAVIA | NDA208843 | |
| MACRILEN | macimorelin acetate | AETERNA ZENTARIS | NDA205598 | |
| PREXXARTAN | valsartan | CARMEL BIOSCIENCES | NDA209139 | |
| SEGLUROMET | ertugliflozin, metformin hydrochloride | MSD SUB MERCK | NDA209806 | |
| STEGLATRO | ertugliflozin | MSD SUB MERCK | NDA209803 | |
| STEGLUJAN | ertugliflozin, sitagliptin phosphate | MSD SUB MERCK | NDA209805 | |
| RHOPRESSA | netarsudil mesylate | ALCON LABS INC | NDA208254 | |
| MEDICAL AIR, USP | medical air | LINDE GAS PUERTO RICO INC | NDA211270 | |
| ALTAFLUOR BENOX | benoxinate hydrochloride, fluorescein sodium | ALTAIRE PHARMS INC | NDA208582 | |
| ESKATA | hydrogen peroxide | ACLARIS | NDA209305 | |
| GOPRELTO | cocaine hydrochloride | LXO IRELAND | NDA209963 | |
| IXIFI | infliximab-qbtx | PFIZER INC | BLA761072 | |
| ADMELOG | insulin lispro | SANOFI-AVENTIS US | BLA209196 | |
| XEPI | ozenoxacin | LNHC | NDA208945 | |
| SINUVA | mometasone furoate | INTERSECT ENT INC | NDA209310 | |
| LONHALA MAGNAIR KIT | glycopyrrolate | SUMITOMO PHARMA AM | NDA208437 | |
| OZEMPIC | semaglutide | NOVO | NDA209637 | |
| OGIVRI | trastuzumab-dkst | MYLAN GMBH | BLA761074 | |
| SUBLOCADE | buprenorphine | INDIVIOR | NDA209819 | |
| CLENPIQ | citric acid, magnesium oxide, sodium picosulfate | FERRING PHARMS INC | NDA209589 | |
| IMPOYZ | clobetasol propionate | PRIMUS PHARMS | NDA209483 | |
| JULUCA | dolutegravir sodium, rilpivirine hydrochloride | VIIV HLTHCARE | NDA210192 | |
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | FRESENIUS KABI USA | NDA208109 | |
| HEMLIBRA | emicizumab | GENENTECH INC | BLA761083 | |
| MEPSEVII | vestronidase alfa-vjbk | ULTRAGENYX PHARM INC | BLA761047 | |
| FASENRA | benralizumab | ASTRAZENECA AB | BLA761070 | |
| TEKTURNA | aliskiren hemifumarate | NODEN PHARMA | NDA210709 | |
| ABILIFY MYCITE KIT | aripiprazole | OTSUKA | NDA207202 | |
| CINVANTI | aprepitant | HERON THERAPS INC | NDA209296 | |
| PREVYMIS | letermovir | MERCK SHARP DOHME | NDA209939 | |
| PREVYMIS | letermovir | MERCK SHARP DOHME | NDA209940 | |
| BORTEZOMIB | bortezomib | FRESENIUS KABI USA | NDA205004 | |
| VYZULTA | latanoprostene bunod | BAUSCH AND LOMB | NDA207795 | |
| CALQUENCE | acalabrutinib | ASTRAZENECA | NDA210259 | |
| VARUBI | rolapitant hydrochloride | TERSERA | NDA208399 | |
| BYDUREON BCISE | exenatide synthetic | ASTRAZENECA AB | NDA209210 | |
| DAPTOMYCIN | daptomycin | HIKMA | NDA209949 | |
| LYRICA CR | pregabalin | UPJOHN | NDA209501 | |
| ZILRETTA | triamcinolone acetonide | PACIRA PHARMS INC | NDA208845 | |
| ASCOR | ascorbic acid | MCGUFF | NDA209112 | |
| FIASP PENFILL | insulin aspart | NOVO | BLA208751 | |
| VERZENIO | abemaciclib | ELI LILLY AND CO | NDA208716 | |
| CLOROTEKAL | chloroprocaine hydrochloride | B BRAUN MEDICAL | NDA208791 | |
| TRELEGY ELLIPTA | fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | GLAXOSMITHKLINE | NDA209482 | |
| XHANCE | fluticasone propionate | PARATEK PHARMS | NDA209022 | |
| ADZENYS ER | amphetamine | NEOS THERAPS INC | NDA204325 | |
| SOLOSEC | secnidazole | EVOFEM INC | NDA209363 | |
| ALIQOPA | copanlisib dihydrochloride | BAYER HEALTHCARE | NDA209936 | |
| MVASI | bevacizumab-awwb | AMGEN INC | BLA761028 | |
| DAPTOMYCIN | daptomycin | SAGENT PHARMS INC | NDA208385 | |
| TRACLEER | bosentan | ACTELION | NDA209279 | |
| OXYGEN, USP | oxygen | PRAXAIR MEXICO | NDA210844 | |
| MYLOTARG | gemtuzumab ozogamicin | WYETH PHARMS INC | BLA761060 | |
| AUSTEDO | deutetrabenazine | TEVA BRANDED PHARM | NDA209885 | |
| BENZNIDAZOLE | benznidazole | CHEMO RESEARCH SL | NDA209570 | |
| VABOMERE | meropenem, vaborbactam | REMPEX | NDA209776 | |
| CYLTEZO | adalimumab-adbm | BOEHRINGER INGELHEIM | BLA761058 | |
| GOCOVRI | amantadine hydrochloride | SUPERNUS PHARMS | NDA208944 | |
| CARBON DIOXIDE, USP | carbon dioxide | LISS AMERICA LLC | NDA210816 | |
| DUZALLO | allopurinol, lesinurad | IRONWOOD PHARMS INC | NDA209203 | |
| BESPONSA | inotuzumab ozogamicin | WYETH PHARMS INC | BLA761040 | |
| DRAX EXAMETAZIME | technetium tc-99m exametazime kit | JUBILANT | NDA208870 | |
| LYNPARZA | olaparib | ASTRAZENECA | NDA208558 | |
| CAROSPIR | spironolactone | CMP DEV LLC | NDA209478 | |
| NIKITA | pitavastatin sodium | LUPIN | NDA209875 | |
| GEMCITABINE HYDROCHLORIDE | gemcitabine hydrochloride | ACCORD HLTHCARE | NDA209604 | |
| MAVYRET | glecaprevir, pibrentasvir | ABBVIE | NDA209394 | |
| QVAR REDIHALER | beclomethasone dipropionate | NORTON WATERFORD | NDA207921 | |
| VYXEOS | cytarabine, daunorubicin | JAZZ PHARMS THERAP | NDA209401 | |
| IDHIFA | enasidenib mesylate | BRISTOL MYERS SQUIBB | NDA209606 | |
| HARLIKU | nitisinone | CYCLE | NDA209449 | |
| BENLYSTA | belimumab | GLAXOSMITHKLINE LLC | BLA761043 | |
| VOSEVI | sofosbuvir, velpatasvir, voxilaprevir | GILEAD SCIENCES INC | NDA209195 | |
| NERLYNX | neratinib maleate | PUMA BIOTECH | NDA208051 | |
| ZYPITAMAG | pitavastatin magnesium | MEDICURE | NDA208379 | |
| TREMFYA | guselkumab | JANSSEN BIOTECH | BLA761061 | |
| ENDARI | l-glutamine | EMMAUS MEDCL | NDA208587 | |
| OMEPRAZOLE | omeprazole | DEXCEL | NDA209400 | |
| PANTOPRAZOLE SODIUM | pantoprazole sodium | HIKMA | NDA209463 | |
| TRIPTODUR KIT | triptorelin pamoate | AZURITY | NDA208956 | |
| BEVYXXA | betrixaban | PORTOLA PHARMS INC | NDA208383 | |
| RITUXAN HYCELA | rituximab, hyaluronidase (human recombinant) | GENENTECH INC | BLA761064 | |
| MYDAYIS | amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate | TAKEDA PHARMS USA | NDA022063 | |
| BAXDELA | delafloxacin meglumine | MELINTA | NDA208610 | |
| BAXDELA | delafloxacin meglumine | MELINTA | NDA208611 | |
| COTEMPLA XR-ODT | methylphenidate | NEOS THERAPS INC | NDA205489 | |
| CALCIUM GLUCONATE | calcium gluconate | FRESENIUS KABI USA | NDA208418 | |
| SYMJEPI | epinephrine | ADAMIS PHARMS CORP | NDA207534 | |
| NORVIR | ritonavir | ABBVIE | NDA209512 | |
| GLEOLAN | aminolevulinic acid hydrochloride | NXDC | NDA208630 | |
| ZERVIATE | cetirizine hydrochloride | HARROW EYE | NDA208694 | |
| KEVZARA | sarilumab | SANOFI SYNTHELABO | BLA761037 | |
| JADENU SPRINKLE | deferasirox | NOVARTIS | NDA207968 | |
| BAVENCIO | avelumab | EMD SERONO INC | BLA761078 | |
| MINOLIRA | minocycline hydrochloride | EPI HLTH | NDA209269 | |
| RADICAVA | edaravone | SHIONOGI | NDA209176 | |
| KISQALI FEMARA CO-PACK (COPACKAGED) | letrozole, ribociclib succinate | NOVARTIS | NDA209935 | |
| IMFINZI | durvalumab | ASTRAZENECA UK LTD | BLA761069 | |
| STERITALC | talc | NOVATECH SA | NDA205555 | |
| ALUNBRIG | brigatinib | TAKEDA PHARMS USA | NDA208772 | |
| RYDAPT | midostaurin | NOVARTIS | NDA207997 | |
| TYMLOS | abaloparatide | RADIUS | NDA208743 | |
| BRINEURA | cerliponase alfa | BIOMARIN PHARM | BLA761052 | |
| XATMEP | methotrexate sodium | AZURITY | NDA208400 | |
| RENFLEXIS | infliximab-abda | SAMSUNG BIOEPIS CO LTD | BLA761054 | |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | clindamycin phosphate | BAXTER HLTHCARE CORP | NDA208083 | |
| ROXYBOND | oxycodone hydrochloride | PROTEGA PHARMS | NDA209777 | |
| INGREZZA | valbenazine tosylate | NEUROCRINE | NDA209241 | |
| AUSTEDO | deutetrabenazine | TEVA BRANDED PHARM | NDA208082 | |
| DUPIXENT | dupilumab | REGENERON PHARMACEUTICALS | BLA761055 | |
| OCREVUS | ocrelizumab | GENENTECH INC | BLA761053 | |
| ZEJULA | niraparib tosylate | GLAXOSMITHKLINE | NDA208447 | |
| BAVENCIO | avelumab | EMD SERONO INC | BLA761049 | |
| SYMPROIC | naldemedine tosylate | BDSI | NDA208854 | |
| XADAGO | safinamide mesylate | MDD US | NDA207145 | |
| LAMIVUDINE AND ZIDOVUDINE | lamivudine, zidovudine | PHARMACARE | NDA022018 | |
| KISQALI | ribociclib succinate | NOVARTIS | NDA209092 | |
| VORICONAZOLE | voriconazole | HIKMA | NDA208562 | |
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | sodium nitroprusside | EXELA PHARMA | NDA209387 | |
| NITROUS OXIDE, USP | nitrous oxide | PRAXAIR DISTRIBUTION INC | NDA210235 | |
| NOCTIVA | desmopressin acetate | ACERUS PHARMS | NDA201656 | |
| EPHEDRINE SULFATE | ephedrine sulfate | RENEW PHARMS | NDA208609 | |
| XERMELO | telotristat etiprate | TERSERA | NDA208794 | |
| QTERN | dapagliflozin, saxagliptin hydrochloride | ASTRAZENECA AB | NDA209091 | |
| GANZYK-RTU | ganciclovir | EXELA PHARMA | NDA209347 | |
| SILIQ | brodalumab | VALEANT LUXEMBOURG | BLA761032 | |
| EMFLAZA | deflazacort | PTC THERAP | NDA208684 | |
| EMFLAZA | deflazacort | PTC THERAP | NDA208685 | |
| PARSABIV | etelcalcetide | KAI PHARMS INC | NDA208325 | |
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA209089 | |
| XYZAL ALLERGY 24HR | levocetirizine dihydrochloride | CHATTEM SANOFI | NDA209090 | |
| VYVANSE | lisdexamfetamine dimesylate | TAKEDA PHARMS USA | NDA208510 | |
| AIRDUO DIGIHALER | fluticasone propionate, salmeterol xinafoate | TEVA PHARM | NDA208799 | |
| ARMONAIR RESPICLICK | fluticasone propionate | TEVA PHARM | NDA208798 | |
| CORPHEDRA | ephedrine sulfate | PH HEALTH | NDA208943 | |
| TEPADINA AND SODIUM CHLORIDE | thiotepa | ADIENNE SA | NDA208264 | |
| TRULANCE | plecanatide | SALIX | NDA208745 | |
| RHOFADE | oxymetazoline hydrochloride | MAYNE PHARMA | NDA208552 | |
| VANTRELA ER | hydrocodone bitartrate | TEVA BRANDED PHARM | NDA207975 | |
| ESBRIET | pirfenidone | LEGACY | NDA208780 | |
| ARYMO ER | morphine sulfate | ZYLA | NDA208603 | |
| NITROUS OXIDE, USP | nitrous oxide | MATHESON TRI-GAS INC | NDA209989 |