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EU-Arzneimittelzulassungen (human) • EU-Arzneimittelzulassungen (veterinär) • USA-Arzneimittelzulassungen (human)
| No.[2] | Brand name | API | MA-Date | ATC-Code |
|---|---|---|---|---|
| BLA 761344 | Imdelltra neu | tarlatamab-dlle | 16.05.2024 | |
| NDA 218709 | Xolremdi neu | mavorixafor | 26.04.2024 | |
| NDA 218033 | Ojemda neu | tovorafenib | 23.04.2024 | |
| BLA 761336 | Anktiva neu | Nogapendekin alfa Inbakicept-pmln | 22.04.2024 | |
| NDA 214511 | Lumisight | Pegulicianin | 17.04.2024 | |
| NDA 218275 | Zevtera | Ceftobiprolmedocaril-Natrium | 03.04.2024 | |
| NDA 218037 | Voydeya | danicopan | 29.3.20240 | |
| NDA 215192 | Vafseo | vadadustat | 27.03.2024 | |
| BLA 761363 | Winrevair | sotatercept-csrk | 26.03.2024 | |
| NDA 217865 | Duvyzat | Givinostat | 21.03.2024 | |
| NDA 217686 | Tryvio | Aprocitentan | 19.03.2024 | |
| STN 125758 | Lenmeldy neu | atidarsagene autotemcel | 18.03.2024 | |
| NDA 217785 | Rezdiffra | resmetirom | 14.03.2024 | |
| BLA 761232 | Tevimbra | tislelizumab-jsgr | 13.03.2024 | |
| BLA 761225 | Letybo | letibotulinumtoxin A-wlbg | 29.02.2024 | |
| NDA 217424 | Exblifep | cefepime, enmetazobactam | 22.02.2024 | |
| STN 125773 | Amtagvi | lifileucel | 16.02.2024 | L01XL11 |
| NDA 217424 | Zelsuvmi | berdazimer | 05.01.2024 | |
| NDA 217388 | Wainua | eplontersen | 21.12.2023 | |
| NDA 215064 | Filsuvez | Birkenrindenterpene | 18.12.2023 | |
| STN 125785/7 | Casgevy | exagamglogene autotemcel | 08.12.2023 | |
| STN 125788 | Lyfgenia | lovotibeglogene autotemcel | 08.12.2023 | |
| NDA 218276 | Fabhalta | iptacopan | 05.12.2023 | |
| NDA 217677 | Ogsiveo | nirogacestat | 27.11.2023 | |
| NDA 218197 | Truqap | capivasertib | 16.11.2023 | |
| BLA 761134 | Ryzneuta | efbemalenograstim alfa-vuxw | 16.11.2023 | |
| NDA 218213 | Augtyro | repotrectinib | 15.11.2023 | |
| NDA 214520 | DefenCath | taurolidine, heparin | 15.11.2023 | |
| NDA 217564 | Fruzaqla | fruquintinib | 08.11.2023 | |
| BLA 761285 | Wezlana | ustekinumab-auub (Biosimilar) | 31.10.2023 | |
| BLA 761240 | Loqtorzi | toripalimab-tpzi | 27.10.2023 | |
| BLA 761279 | Omvoh | mirikizumab-mrkz | 26.10.2023 | |
| NDA 215239 | Agamree | vamorolone | 26.10.2023 | |
| STN: 125770 | Penbraya | Meningococcal Groups A, B, C, W, and Y Vaccine | 20.10.2023 | |
| STN: 125792 | Elecsys HTLV-I/II | in vitro immunoassay for the qualitative detection of antibodies to HTLV-I and HTLV-II in human serum/plasma | 17.10.2023 | |
| BLA 761151 | Bimzelx | bimekizumab | 17.10.2023 | |
| NDA 216834 | Zilbrysq | zilucoplan | 17.10.2023 | |
| NDA 216956 | Velsipity | etrasimod | 12.10.2023 | |
| NDA 215842 | Rivfloza | nedosiran | 29.09.2023 | |
| BLA 761204 | Pombiliti | cipaglucosidase alfa-atga | 28.09.2023 | |
| NDA 021164 | Exxua | gepirone | 22.09.2023 | |
| NDA 216873 | Ojjaara | momelotinib | 15.09.2023 | |
| NDA 217159 | Aphexda | motixafortide | 08.09.2023 | |
| NDA 217581 | Xalkori | crizotinib | 07.09.2023 | |
| BLA 761322 | Tyruko | natalizumab-sztn (biosimilar) | 24.08.2023 | |
| NDA 216686 | Focinvez | fosaprepitant | 22.08.2023 | |
| STN 125769 | Abrysvo | Respiratory Syncytial Virus Vaccine, (RSV preF A & RSV preF B) | 21.08.2023 | |
| BLA 761339 | Veopoz | pozelimab | 18.08.2023 | |
| BLA 761355 | Eylea HD | aflibercept | 18.08.2023 | |
| NDA 215559 | Sohonos | palovarotene | 16.08.2023 | |
| NDA 201848 | Hepzato Kit | melphalan | 14.08.2023 | |
| BLA 761345 | Elrexfio | elranatamab | 14.08.2023 | |
| NDA 216793 | Akeega | niraparib / abiraterone acetate | 11.08.2023 | |
| BLA 761342 | Talvey | talquetamab-tgvs | 09.08.2023 | |
| NDA 217225 | Izervay | avacincaptad pegol | 04.08.2023 | |
| NDA 217369 | Zurzuvae | zuranolone | 04.08.2023 | |
| NDA 217722 | Rivive | naloxone | 28.08.2023 | |
| NDA 215212 | Meropenem | meropenem | 26.07.2023 | |
| NDA 217603 | Xdemvy | lotilaner | 24.07.2023 | |
| STN 125776/0 | Balfaxar | prothrombin complex concentrate, human-lans | 21.07.2023 | |
| NDA 212905 | Ycanth | cantharidin | 21.07.2023 | |
| STN 125761/0 | Cyfendus | Anthrax Vaccine Adsorbed, Adjuvanted | 20.07.2023 | |
| NDA 216993 | Vanflyta | quizartinib | 20.07.2023 | |
| BLA 761328 | Beyfortus | nirsevimab-alip | 17.07.2023 | J06BD08 |
| STN 125720 | Roctavian | valoctocogene roxaparvovec-rvox | 29.06.2023 | |
| STN 125734 | Lantidra | donislecel-jujn | 28.06.2023 | |
| BLA 761184 | Ngenla | somatrogon-ghla | 27.06.2023 | |
| BLA 761286 | Rystiggo | rozanolixizumab-noli | 26.06.2023 | |
| NDA 215830 | Litfulo | ritlecitinib | 22.06.2023 | |
| STN 125781 | Elevidys | delandistrogene moxeparvovec-rokl | 23.06.2023 | |
| BLA 761309 | Columvi | glofitamab-gxbm | 15.06.2023 | L01FX28 |
| STN 125769 | Abrysvo | Respiratory Syncytial Virus Vaccine, (RSV preF A & RSV preF B) | 31.05.2023 | |
| NDA 216203 | Inpefa | sotagliflozin | 26.05.2023 | A10BK06 |
| NDA 216023 | Posluma | flotufolastat F 18 | 25.05.2023 | |
| NDA 217188 | Paxlovid | nirmatrelvir, ritonavir | 25.05.2023 | |
| NDA 210136 | Brixadi | buprenorphine | 23.05.2023 | |
| NDA 216974 | Xacduro | sulbactam, durlobactam | 23.05.2023 | |
| NDA 217470 | Opvee | nalmefene | 22.05.2023 | |
| BLA 761324 | Epkinly | epcoritamab-bysp | 19.05.2023 | |
| STN 125774 | Vyjuvek | beremagene geperpavec-svdt | 19.05.2023 | |
| NDA 216675 | Miebo | perfluorhexyloctane | 18.05.2023 | |
| NDA 216578 | Veozah | fezolinetant | 12.05.2023 | G02CX06 |
| BLA 761161 | Elfabrio | pegunigalsidase alfa-iwxj | 09.05.2023 | A16AB20 |
| STN 125775 | Arexvy | Respiratory Syncytial Virus Vaccine, Adjuvanted (RSVPreF3) | 03.05.2023 | |
| STN 125757 | Vowst | fecal microbiota spores, live-brpk | 26.04.2023 | |
| NDA 215887 | Qalsody | tofersen | 25.04.2023 | |
| STN 125738 | Omisirge | omidubicel-onlv | 18.04.2023 | |
| NDA 217759 | Joenja | leniolisib | 24.03.2023 | |
| NDA 217417 | Rezzayo | rezafungin | 22.03.2023 | J02AX08 |
| BLA 761334 | Zynyz | retifanlimab-dlwr | 22.03.2023 | L01FF10 |
| NDA 217026 | Daybue | trofinetide | 10.03.2023 | |
| NDA 216386 | Zavzpret | zavegepant | 09.03.2023 | |
| NDA 216718 | Skyclarys | omaveloxolone | 28.02.2023 | |
| STN 125771 | Altuviiio | Fc-VWF-XTEN fusion protein-ehtl | 22.02.2023 | |
| NDA 216951 | Filspari | sparsentan | 17.02.2023 | |
| BLA 761278 | Lamzede | velmanase alfa-tycv | 16.02.2023 | |
| NDA 216951 | Jesduvroq | daprodustat | 01.02.2023 | B03XA07 |
| NDA 217639 | Orserdu | elacestrant | 27.01.2023 | |
| NDA 216059 | Jayprica | tobrutinib | 27.01.2023 | |
| NDA 214373 | Brenzavvy | bexaglifozin | 20.01.2023 | A10BK |
| BLA 761269 | Leqembi | lecanemab-irmb | 06.01.2023 | |
| BLA 761192 | NexoBrid | anacaulase-bcdb | 28.12.2022 | D03BA03 |
| BLA 761238 | Briumvi | ublituximab-xiiy | 28.12.2022 | L04AA57 |
| NDA 214375 | Xenoview | hyperpolarized Xe-129 | 23.12.2022 | |
| BLA 761263 | Lunsumio | mosunetuzumab-axgb | 22.12.2022 | L01XC |
| NDA 215973 | Sunlenca | lenacapavir | 22.12.2022 | J05AX31 |
| NDA 216340 | Krazati | adagrasib | 12.12.2022 | |
| NDA 215814 | Rezlidhia | olutasidenib | 01.12.2022 | |
| STN 125739 | Rebyota | fecal microbiota, live-jslm | 30.11.2022 | |
| STN 125772 | Hemgenix | etranacogene dezaparvovec-drlb | 22.11.2022 | |
| BLA 761183 | Tzield | teplizumab-mzwv | 18.11.2022 | |
| BLA 761310 | Elahere | mirvetuximab soravtansine-gynx | 14.11.2022 | |
| BLA 761291 | Tecvayli | teclistamab-cqyv | 25.10.2022 | |
| BLA 761289 | Imjudo | tremelimumab | 21.10.2022 | L01FX20 |
| NDA 214801 | Lytgobi | futibatinib | 30.09.2022 | L01EN04 |
| NDA 216660 | Relyvrio | sodium phenylbutyrate / taurursodiol | 29.09.2022 | |
| NDA 215092 | Omlonti | omidenepag isopropyl | 22.09.2022 | |
| NDA 216986 | Elucirem | gadopiclenol | 21.09.2022 | V08CA12 |
| STN 125755 | Skysona | elivaldogene autotemcel | 16.09.2022 | A16AX21 |
| NDA 022231 | Terlivaz | terlipressin | 14.09.2022 | H01BA04 |
| BLA 761148 | Rolvedon | eflapegrastim | 09.09.2022 | |
| NDA 214958 | Sotyktu | deucravacitinib | 09.09.2022 | L04AA56 |
| BLA 761127 | Daxxify | daxibotulinumtoixn A-lanm | 07.09.2022 | |
| BLA 761244 | Spevigo | spesolimab-sbzo | 01.09.2022 | |
| BLA 761261 | Xenpozyme | Olipudase alfa | 31.08.2022 | A16AB25 |
| STN 125717 | Zynteglo | betibeglogene autotemcel | 17.08.2022 | B06AX02 |
| STN 125759 | Alinity s Anti-HCV II Reagent Kit | Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide | 15.07.2022 | |
| NDA 215515 | Amvuttra | vutrisiran | 13.06.2022 | |
| STN 125748 | Priorix | Measles, Mumps and Rubella Vaccine Live | 03.06.2022 | J07BD52 |
| NDA 215272 | Vtama | tapinarof | 23.05.2022 | |
| STN 125711 | DG Gel 8 Direct Coombs (Anti-C3d) | Anti-Human Globulin (Murine Monoclonal) | 20.05.2022 | |
| STN 125705 | DG Gel 8 Direct Coombs (Anti-IgG, -C3d) | Anti-Human Globulin (Rabbit/Murine Monoclonal) | 20.05.2022 | |
| STN 125708 | Anti-Human Globulin Anti-IgG, -C3d FFMU, Rabbit Polyclonal/Murine Monoclonal | Anti-Human Globulin (Rabbit/Murine Monoclonal) (For Further Manufacturing Use) | 20.05.2022 | |
| STN 125707 | Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal | Anti-Human Globulin (Murine Monoclonal) (For Further Manufacturing Use) | 20.05.2022 | |
| NDA 215866 | Mounjaro | tirzepatide | 13.05.2022 | |
| NDA 214998 | Camzyos | mavacamten | 28.04.2022 | C01EB24 |
| NDA 215888 | Vivjoa | oteseconazole | 26.04.2022 | J02AC06 |
| NDA 215833 | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 23.03.2022 | |
| BLA 761234 | Opdualag | nivolumab and relatlimab-rmbw | 18.03.2022 | L01XY03 |
| NDA 215904 | Ztalmy | ganaxolone | 18.03.2022 | N03AX27 |
| NDA 215152 | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 05.03.2022 | A02BD14 |
| NDA 208712 | Vonjo | pacritinib | 28.02.2022 | L01EJ03 |
| STN 125746 | Carvykty | ciltacabtagene autoleucel | 28.02.2022 | L01XL05 |
| NDA 216196 | Pyrukynd | mitapivat | 17.02.2022 | B06AX04 |
| BLA 761164 | Enjaymo | sutimlimab-jome | 04.02.2022 | L04AA55 |
| STN 125752 | Spikevax | COVID-19 Vaccine, mRNA | 31.01.2022 | J07BX03 |
| BLA 761235 | Vabysmo | faricimab-svoa | 28.01.2022 | S01LA09 |
| BLA 761228 | Kimmtrak | tebentafusp-tebn | 25.01.2022 | L01XX75 |
| NDA 213871 | Cibinqo | abrocitinib | 14.01.2022 | D11AH08 |
| NDA 214985 | Quviviq | daridorexant | 07.01.2022 | |
| BLA 761180 | Adbry | tralokinumab-ldrm | 27.12.2021 | D11AH07 |
| NDA 214012 | Leqvio | inclisiran | 22.12.2021 | |
| BLA 761195 | Vyvgart | efgartigimod alfa-fcab | 17.12.2021 | |
| BLA 761224 | Tezspire | tezepelumab-ekko | 17.12.2021 | |
| STN 125737 | Prehevbrio | Hepatitis B Vaccine (Recombinant) | 30.11.2021 | |
| NDA 214907 | Cytalux | pafolacianine | 29.11.2021 | |
| NDA 214938 | Voxzogo | vosoritide | 29.11.2021 | |
| NDA 215596 | Livtencity | maribavir | 23.11.2021 | |
| BLA 761166 | Besremi | ropeginterferon alfa-2b-njft | 12.11.2021 | |
| NDA 215358 | Scemblix | asciminib | 29.10.2021 | |
| STN 125685 | Rethymic | allogeneic processed Thymus Tissue | 08.10.2021 | |
| NDA 214487 | Tavneos | avacopan | 07.10.2021 | |
| NDA 214662 | Livmarli | maralixibat | 29.09.2021 | |
| NDA 215206 | Qulipta | atogepant | 28.09.2021 | |
| BLA 761208 | Tivdak | tisotumab vedotin-tftv | 20.09.2021 | |
| NDA 215310 | Exkivity | mobocertinib | 15.09.2021 | |
| BLA 761177 | Skytrofa | lonapegsomatropin-tcgd | 25.08.2021 | |
| NDA 214916 | Korsuva | difelikefalin | 23.08.2021 | |
| STN 125742 | Comirnaty | COVID-19 Vaccine, mRNA | 23.08.2021 | |
| NDA 215383 | Welireg | belzutifan | 13.08.2021 | |
| BLA 761194 | Nexviazyme | avalglucosidase alfa-ngpt | 06.08.2021 | |
| BLA 761123 | Saphnelo | anifrolumab-fnia | 30.07.2021 | |
| NDA 215498 | Bylvay | odevixibat | 20.07.2021 | |
| NDA 214783 | Rezurock | belumosudil | 16.07.2021 | |
| NDA 214429 | Fexinidazole | fexinidazole | 16.07.2021 | |
| STN 125741 | Vaxneuvance | Pneumococcal 15-valent Conjugate Vaccine | 16.07.2021 | |
| NDA 215341 | Kerendia | finerenone | 09.07.2021 | |
| BLA 761179 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 20.06.2021 | |
| STN 012573 | StrataGraft | Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat | 15.06.2021 | |
| STN 125731 | Prevnar 20 | Pneumococcal 20-valent Conjugate Vaccine | 08.06.2021 | |
| BLA 761178 | Aduhelm | aducanumab-avwa | 07.06.2021 | |
| STN 125659 | Ryplazim | plasminogen, human-tvmh | 04.06.2021 | |
| NDA 214900 | Brexafemme | ibrexafungerp | 01.06.2021 | |
| NDA 213378 | Lybalvi | olanzapine and samidorphan | 28.05.2021 | |
| NDA 214622 | Truseltiq | infigratinib | 28.05.2021 | |
| NDA 214665 | Lumakras | sotorasib | 28.05.2021 | |
| NDA 214793 | Pylarify | piflufolastat F 18 | 26.05.2021 | |
| BLA 761210 | Rybrevant | amivantamab-vmjw | 21.05.2021 | |
| NDA 215014 | Empaveli | pegcetacoplan | 23.04.2021 | |
| BLA 761196 | Zynlonta | loncastuximab tesirine-lpyl | 22.04.2021 | |
| BLA 761174 | Jemperli | dostarlimab-gxly | 22.04.2021 | |
| NDA 214154 | Nextstellis | drospirenone and estetrol | 15.04.2021 | |
| NDA 211964 | Qelbree | viloxazine | 02.04.2021 | |
| STN 125736 | Abecma | idecabtagene vicleucel | 26.03.2021 | |
| NDA 214231 | Zegalogue | dasiglucagon | 22.03.2021 | |
| NDA 213498 | Ponvory | ponesimod | 18.03.2021 | |
| NDA 212904 | Fotivda | tivozanib | 10.03.2021 | |
| NDA 212994 | Azstarys | serdexmethylphenidate and dexmethylphenidate | 02.03.2021 | |
| NDA 214383 | Pepaxto | melphalan flufenamide | 26.02.2021 | |
| NDA 214018 | Nulibry | fosdenopterin | 26.02.2021 | |
| NDA 213026 | Amondys 45 | casimersen | 25.02.2021 | |
| NDA 214200 | Cosela | trilacicilib | 12.02.2021 | |
| BLA 761181 | Evkeeza | evinacumab-dgnb | 11.02.2021 | |
| NDA 213176 | Ukoniq | umbralisib | 05.02.2021 | |
| STN 125714 | Breyanzi | lisocabtagene maraleucel | 05.02.2021 | |
| NDA 214096 | Tepmetko | tepotinib | 03.02.2021 | |
| NDA 212716 | Lupkynis | voclosporin | 22.01.2021 | |
| NDA 212888 | Cabenuva | cabotegravir and rilpivirine (co-packaged) | 21.01.2021 | |
| NDA 214377 | Verquvo | vericiguat | 19.01.2021 |
- ↑ diese (im Januar 2023 angelegte) Liste ist unvollständig und enthält lediglich ab Anfang 2021 erteilte FDA-Zulassungen für New Drug Applications (NDA) und Biologic License Applications (BLA) (siehe dazu: Types of Applications)
- ↑ NDA = New Drug Application, BLA = Biologic License Application, STN = Submission Tracking Number
Weblinks[Bearbeiten | Quelltext bearbeiten]
- FDA’s Labeling Resources for Human Prescription Drugs
- Drugs@FDA (includes most of the drug products approved since 1939; does not include information about FDA-approved products regulated by the CBER (vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products) or products not approved by the FDA)
- Orange Book (Generics)
- Purple Book (Biologicals)
- OTC monographs
- Green Book (Animal Drug Products)