All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2025
FDA approved the original submission of 148 new drug and biologics license applications in 2025, from 116 sponsors. FDA marks 6 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| NEREUS | tradipitant | VANDA PHARMS INC | NDA220152 | |
| YARTEMLEA | narsoplimab-wuug | OMEROS CORP | BLA761152 | |
| MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM | dextromethorphan hydrobromide, guaifenesin, naproxen sodium | RECKITT BENCKISER | NDA217338 | |
| WEGOVY | semaglutide | NOVO | NDA218316 | |
| BONCRESA | denosumab-mobz | AMNEAL PHARMS LLC | BLA761456 | |
| JASCAYD | nerandomilast | BOEHRINGER INGELHEIM | NDA220449 | |
| MYQORZO | aficamten | CYTOKINETICS | NDA219083 | |
| OZILTUS | denosumab-mobz | AMNEAL PHARMS LLC | BLA761457 | |
| NUFYMCO | ranibizumab-leyk | FORMYCON AG | BLA761473 | |
| RYBREVANT FASPRO | amivantamab and hyaluronidase-lpuj | JANSSEN BIOTECH | BLA761433 | |
| EXDENSUR | depemokimab-ulaa | GLAXOSMITHKLINE LLC | BLA761458 | |
| VYBRIQUE | sildenafil citrate | IBSA | NDA210858 | |
| CARDAMYST | etripamil | MILESTONE PHARMS USA | NDA218571 | |
| LEROCHOL | lerodalcibep-liga | LIB THERAPEUTICS, INC. | BLA761427 | |
| NUZOLVENCE | zoliflodacin | ENTASIS THERAP | NDA219491 | |
| DAYBUE STIX | trofinetide | ACADIA PHARMS INC | NDA219884 | |
| ORLADEYO | berotralstat dihydrochloride | BIOCRYST | NDA219776 | |
| ARMLUPEG | pegfilgrastim-unne | LUPIN LTD | BLA761212 | |
| VOYXACT | sibeprenlimab-szsi | OTSUKA PHARM CO LTD | BLA761434 | |
| HYRNUO | sevabertinib | BAYER HEALTHCARE | NDA219972 | |
| REDEMPLO | plozasiran sodium | ARROWHEAD | NDA219947 | |
| KOMZIFTI | ziftomenib | KURA | NDA220305 | |
| POHERDY | pertuzumab-dpzb | SHANGHAI HENLIUS BIOTECH | BLA761450 | |
| KYGEVVI | doxecitine, doxribtimine | UCB INC | NDA219792 | |
| OSVYRTI | denosumab-desu | ACCORD BIOPHARMA INC. | BLA761424 | |
| CARBON DIOXIDE, USP | carbon dioxide | ROBERTS OXYGEN CO INC | NDA221021 | |
| LYNKUET | elinzanetant | BAYER HLTHCARE | NDA219469 | |
| ROCURONIUM BROMIDE | rocuronium bromide | B BRAUN MEDICAL | NDA219108 | |
| BLENREP | belantamab mafodotin-blmf | GLAXOSMITHKLINE LLC | BLA761440 | |
| DEHYDRATED ALCOHOL | dehydrated alcohol | BE PHARMS | NDA214988 | |
| JAVADIN | clonidine hydrochloride | AZURITY | NDA220256 | |
| CONTEPO | fosfomycin disodium | MEITHEAL | NDA212271 | |
| EPIOXA HD/EPIOXA KIT | riboflavin 5'-phosphate sodium | GLAUKOS | NDA219910 | |
| FERABRIGHT | ferumoxytol | AZURITY | NDA219868 | |
| JASCAYD | nerandomilast | BOEHRINGER INGELHEIM | NDA218764 | |
| LASIX ONYU | furosemide | SQ INNOVATION | NDA217294 | |
| EYDENZELT | aflibercept-boav | CELLTRION INC | BLA761377 | |
| RHAPSIDO | remibrutinib | NOVARTIS | NDA218436 | |
| CLOTIC | clotrimazole | CARWIN PHARM ASSOC | NDA217628 | |
| ENOBY | denosumab-qbde | HIKMA PHARMACEUTICALS USA INC | BLA761439 | |
| INLURIYO | imlunestrant tosylate | ELI LILLY AND CO | NDA218881 | |
| PALSONIFY | paltusotine hydrochloride | CRINETICS | NDA219070 | |
| BONDLIDO | lidocaine | MEDRX USA | NDA215029 | |
| FORZINITY | elamipretide hydrochloride | STEALTH BIOTHERAPS | NDA215244 | |
| KEYTRUDA QLEX | pembrolizumab, berahyaluronidase alfa-pmph | MERCK SHARP DOHME | BLA761467 | |
| AUKELSO | denosumab-kyqq | BIOCON BIOLOGICS INC | BLA761436 | |
| SUBVENITE | lamotrigine | OWP PHARMS | NDA218879 | |
| ENBUMYST | bumetanide | CORSTASIS THERAP | NDA219500 | |
| KOSELUGO | selumetinib, selumetinib sulfate | ASTRAZENECA | NDA219943 | |
| INLEXZO | gemcitabine hydrochloride | JANSSEN BIOTECH | NDA219683 | |
| ZOLYMBUS | bimatoprost | THEA PHARMA | NDA217307 | |
| BILPREVDA | denosumab-nxxp | SHANGHAI HENLIUS BIOTECH | BLA761444 | |
| ESCITALOPRAM | escitalopram oxalate | ALMATICA | NDA219130 | |
| LEQEMBI IQLIK | lecanemab-irmb | EISAI INC | BLA761375 | |
| OTEZLA | apremilast | AMGEN INC | NDA210745 | |
| WAYRILZ | rilzabrutinib | GENZYME CORP | NDA219685 | |
| LOPRESSOR | metoprolol tartrate | XTM CONSULTING | NDA218698 | |
| CAMCEVI ETM | leuprolide mesylate | ACCORD | NDA219745 | |
| DAWNZERA (AUTOINJECTOR) | donidalorsen sodium | IONIS PHARMS INC | NDA219407 | |
| CYKLX | articaine hydrochloride | THEA PHARMA | NDA218643 | |
| TONMYA | cyclobenzaprine hydrochloride | TONIX | NDA219428 | |
| BRINSUPRI | brensocatib | INSMED INC | NDA217673 | |
| HERNEXEOS | zongertinib | BOEHRINGER INGELHEIM | NDA219042 | |
| KYXATA | carboplatin | AVYXA HOLDINGS | NDA219921 | |
| MODEYSO | dordaviprone hydrochloride | CHIMERIX | NDA219876 | |
| E-Z-DISK | barium sulfate | BRACCO | NDA219840 | |
| ALHEMO | concizumab | NOVO NORDISK INC | BLA761428 | |
| VIZZ | aceclidine hydrochloride | LENZ THERAP | NDA218585 | |
| ATMEKSI | methocarbamol | ROSEMONT PHARMS | NDA219843 | |
| VYSCOXA | celecoxib | CARWIN PHARM ASSOC | NDA211759 | |
| SEPHIENCE | sepiapterin | PTC THERAP | NDA219666 | |
| DOPTELET SPRINKLE | avatrombopag maleate | AKARX INC | NDA219696 | |
| SDAMLO | amlodipine besylate | BRILLIAN PHARMA | NDA219531 | |
| ANZUPGO | delgocitinib | LEO PHARMA AS | NDA219155 | |
| VOSTALLY | ramipril | ROSEMONT PHARMS | NDA219757 | |
| FAMOTIDINE | famotidine | SAGENT | NDA219935 | |
| KIRSTY | insulin aspart-xjhz | BIOCON BIOLOGICS INC | BLA761188 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | AVYXA HOLDINGS | NDA219014 | |
| EKTERLY | sebetralstat | KALVISTA | NDA219301 | |
| LYNOZYFIC | linvoseltamab-gcpt | RENGENERON PHARMACEUTICALS, INC. | BLA761400 | |
| ZEGFROVY | sunvozertinib | DIZAL | NDA219839 | |
| AVGEMSI | gemcitabine hydrochloride | AVYXA HOLDINGS | NDA219920 | |
| DATROWAY | datopotamab deruxtecan-dlnk | DAIICHI SANKYO INC | BLA761464 | |
| YEZTUGO | lenacapavir, lenacapavir sodium | GILEAD SCIENCES INC | NDA220018 | |
| YEZTUGO | lenacapavir sodium | GILEAD SCIENCES INC | NDA220020 | |
| ANDEMBRY | garadacimab-gxii | CSL BEHRING LLC | BLA761367 | |
| ARYNTA | lisdexamfetamine dimesylate | AZURITY | NDA219847 | |
| CARBON DIOXIDE, USP | carbon dioxide | GENERAL DISTRIBUTING COMPANY | NDA220634 | |
| ZUSDURI | mitomycin | UROGEN PHARMA | NDA215793 | |
| IBTROZI | taletrectinib adipate | NUVATION | NDA219713 | |
| BRUKINSA | zanubrutinib | BEONE MEDICINES USA | NDA218785 | |
| ENFLONSIA | clesrovimab-cfor | MERCK SHARP DOHME | BLA761432 | |
| ROCURONIUM BROMIDE | rocuronium bromide | FRESENIUS KABI USA | NDA217472 | |
| WIDAPLIK | amlodipine besylate, indapamide, telmisartan | AZURITY | NDA219423 | |
| XIFYRM | meloxicam | AZURITY | NDA218395 | |
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | phenylephrine hydrochloride | DR REDDYS LABS SA | NDA216830 | |
| KHINDIVI | hydrocortisone | ETON | NDA218980 | |
| TRYPTYR | acoltremon | ALCON LABS INC | NDA217370 | |
| YUTREPIA | treprostinil sodium | LIQUIDIA TECH | NDA213005 | |
| STARJEMZA | ustekinumab-hmny | BIO-THERA SOLUTIONS LTD | BLA761419 | |
| BREKIYA (AUTOINJECTOR) | dihydroergotamine mesylate | AMNEAL | NDA215400 | |
| EMRELIS | telisotuzumab vedotin-tllv | ABBVIE INC | BLA761384 | |
| AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | avutometinib potassium, defactinib hydrochloride | VERASTEM INC | NDA219616 | |
| ATZUMI | dihydroergotamine mesylate | SATSUMA PHARMS | NDA217901 | |
| IMAAVY | nipocalimab-aahu | JANSSEN BIOTECH | BLA761430 | |
| PENPULIMAB-KCQX | penpulimab-kcqx | AKESO BIOPHARMA | BLA761258 | |
| QAMZOVA | meloxicam | NANJING DELOVA | NDA217593 | |
| CARBON DIOXIDE, USP | carbon dioxide | MITCHELL WEDLING SUPPLY | NDA220461 | |
| ELIQUIS | apixaban | BRISTOL | NDA220073 | |
| MEZOFY | aripiprazole | CMG PHARM CO LTD | NDA211448 | |
| LIVMARLI | maralixibat chloride | MIRUM | NDA219485 | |
| LOPRESSOR | metoprolol tartrate | RUBICON RESEARCH | NDA219373 | |
| JOBEVNE | bevacizumab-nwgd | BIOCON BIOLOGICS INC | BLA761175 | |
| PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | piperacillin sodium, tazobactam sodium | B BRAUN MEDICAL | NDA206056 | |
| VANRAFIA | atrasentan hydrochloride | NOVARTIS | NDA219208 | |
| QFITLIA | fitusiran sodium | GENZYME CORP | NDA219019 | |
| VYKAT XR | diazoxide choline | SOLENO THERAP | NDA216665 | |
| BLUJEPA | gepotidacin mesylate | GLAXOSMITHKLINE | NDA218230 | |
| CONEXXENCE | denosumab-bnht | FRESENIUS KABI USA LLC | BLA761398 | |
| GOZELLIX | gallium ga-68 gozetotide | TELIX INNOVATIONS | NDA219592 | |
| HEMICLOR | chlorthalidone | PRM PHARMA | NDA218647 | |
| TYENNE | tocilizumab-aazg | FRESENIUS KABI USA | BLA761449 | |
| ARBLI | losartan potassium | SCIENTURE | NDA218772 | |
| EPINEPHRINE | epinephrine | FRESENIUS KABI USA | NDA215425 | |
| OMLYCLO | omalizumab-igec | CELLTRION INC | BLA761399 | |
| TEVIMBRA | islelizumab-jsgr | BEIGENE | BLA761380 | |
| EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | epinephrine bitartrate | BAXTER HLTHCARE CORP | NDA218475 | |
| OSENVELT | denosumab-bmwo | CELLTRION INC | BLA761404 | |
| MIUDELLA | copper | SEBELA WOMENS HLTH | NDA218201 | |
| CTEXLI | chenodiol | MIRUM | NDA219488 | |
| DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | diltiazem hydrochloride | HQ SPCLT PHARMA | NDA218038 | |
| NILOTINIB D-TARTRATE | nilotinib d-tartrate | CIPLA | NDA218922 | |
| MERILOG | insulin aspart-szjj | SANOFI-AVENTIS U.S. LLC | BLA761325 | |
| ROMVIMZA | vimseltinib | DECIPHERA PHARMS | NDA219304 | |
| DENOSUMAB-DSSB | denosumab-dssb | SAMSUNG BIOEPIS CO LTD | BLA761392 | |
| EVRYSDI | risdiplam | GENENTECH INC | NDA219285 | |
| GOMEKLI | mirdametinib | SPRINGWORKS | NDA219379 | |
| GOMEKLI | mirdametinib | SPRINGWORKS | NDA219389 | |
| EMBLAVEO | avibactam sodium, aztreonam | ABBVIE | NDA217906 | |
| ONAPGO | apomorphine hydrochloride | MDD US | NDA214056 | |
| Carbon Dioxide, USP | carbon dioxide | WELDERS SUPPLY COMPANY OF LOUISVILLE INC | NDA220266 | |
| JOURNAVX | suzetrigine | VERTEX PHARMS INC | NDA219209 | |
| SYMBRAVO | meloxicam, rizatriptan benzoate | AXSOME | NDA215431 | |
| INZIRQO | hydrochlorothiazide | NOVITIUM PHARMA | NDA219141 | |
| AVTOZMA | tocilizumab-anoh | CELLTRION INC | BLA761420 | |
| GRAFAPEX | treosulfan | MEDEXUS | NDA214759 | |
| DATROWAY | datopotamab deruxtecan-dlnk | DAIICHI SANKYO INC | BLA761394 | |
| BRYNOVIN | sitagliptin hydrochloride | AZURITY | NDA219122 |