Ukuqamba okusha kuqhubekisela phambili inqubekelaphambili. Uma kuziwa ekwenziweni okusha ekuthuthukisweni kwemithi emisha nemikhiqizo yebhayoloji yokwelapha, Isikhungo Sezidakamizwa Sokuhlola Nokucwaninga (CDER) se-FDA sisekela imboni yezokwelapha kuzo zonke izinyathelo zenqubo. Ngokuqonda kwayo isayensi esetshenziselwa ukudala imikhiqizo emisha, izinqubo zokuhlola nokukhiqiza, kanye nezifo nezimo imikhiqizo emisha eklanyelwe ukuzelapha, i-CDER inikeza iseluleko sesayensi nesokulawula esidingekayo ukuze kulethwe izindlela zokwelapha ezintsha emakethe.
Ukutholakala kwemithi emisha nemikhiqizo yebhayoloji kuvame ukusho izindlela ezintsha zokwelapha iziguli kanye nentuthuko ekunakekelweni kwezempilo komphakathi waseMelika. Ngalesi sizathu, i-CDER isekela ukuqanjwa kabusha futhi idlala indima ebalulekile ekusizeni ukuthuthukiswa kwezidakamizwa ezintsha.
Unyaka ngamunye, i-CDER igunyaza izinhlobonhlobo zemithi emisha nemikhiqizo yebhayoloji:
1. Eminye yale mikhiqizo iyimikhiqizo emisha engakaze isetshenziswe emtholampilo. Ngezansi kunohlu lwezinhlaka ezintsha zamangqamuzana nemikhiqizo emisha yokwelapha egunyazwe i-CDER ngo-2021. Lolu hlu alunayo imithi yokugoma, imikhiqizo engezwani nomzimba, igazi nemikhiqizo yegazi, okuphuma ku-plasma, imikhiqizo yokwelapha yamaselula kanye nofuzo, noma eminye imikhiqizo egunyazwe ngo-2021 Isikhungo Sokuhlola Nokucwaninga Kwebhayoloji.
2. Eminye iyafana, noma ihlobene nemikhiqizo egunyazwe ngaphambilini, futhi izoqhudelana naleyo mikhiqizo esigcawini. Bheka Drugs@FDA ukuze uthole ulwazi mayelana nayo yonke imithi egunyaziwe ye-CDER kanye nemikhiqizo yebhayoloji.
Izidakamizwa ezithile zihlukaniswa njengezinhlaka ezintsha zamangqamuzana ("NMEs") ngezinjongo zokubuyekezwa kwe-FDA. Eminingi yale mikhiqizo iqukethe izingxenye ezisebenzayo ezingazange zigunyazwe yi-FDA ngaphambilini, kungaba njengesithako esisodwa somuthi noma njengengxenye yomkhiqizo oyinhlanganisela; le mikhiqizo ivamise ukuhlinzeka ngemithi emisha ebalulekile ezigulini. Eminye imithi ibonakala njengama-NME ngezinjongo zokuphatha, kodwa noma kunjalo iqukethe izingxenye ezisebenzayo ezihlobene eduze nezingxenye ezisebenzayo emikhiqizweni egunyazwe ngaphambilini yi-FDA. Isibonelo, i-CDER ihlukanisa imikhiqizo yebhayoloji efakwe esicelweni ngaphansi kwesigaba 351 (a) soMthetho Wesevisi Yezempilo Yomphakathi njengama-NME ngezinjongo zokubuyekezwa kwe-FDA, kungakhathaliseki ukuthi i-Ejensi ngaphambilini yayigunyaze yini ingxenye esebenzayo ehlobene emkhiqizweni ohlukile. Ukuhlukaniswa kwe-FDA komuthi njenge-"NME" ngezinjongo zokubuyekeza kuhlukile ekunqumeni kwe-FDA ukuthi ingabe umkhiqizo wesidakamizwa "uyibhizinisi elisha lamakhemikhali" noma "i-NCE" ngokwencazelo ye-Federal Food, Drug, and Cosmetic Act.
| Cha. | Igama lezidakamizwa | Isithako Esisebenzayo | Usuku Lokugunyazwa | Ukusetshenziswa okugunyazwe yi-FDA ngosuku lokugunyazwa* |
| 37 | Exkivity | mobocertinib | 9/15/2021 | Ukwelapha umdlavuza wamaphaphu osethuthukile endaweni noma ongewona omncane we-metastatic nge-epidermal growth factor receptor exon 20 |
| 36 | I-Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | Ukwelapha ubude obufushane ngenxa yokungakhiqizi ngokwanele kwe-endogenous growth hormone |
| 35 | Korsuva | ifanefalin | 8/23/2021 | Ukwelapha ukulunywa okumaphakathi kuya kokuqina okuhambisana nesifo sezinso esingamahlalakhona kubantu abathile |
| 34 | Welileg | i-belzutifan | 8/13/2021 | Ukwelapha isifo se-von Hippel-Lindau ngaphansi kwezimo ezithile |
| 33 | I-Nexviazyme | i-avalglucosidase alfa-ngpt | 8/6/2021 | Ukwelapha isifo sePompe esiqala sekwephuzile |
| Isitatimende sephephandaba | ||||
| 32 | Saphnelo | i-anifrolumab-fnia | 7/30/2021 | Ukwelapha i-systemic lupus erythematousus emaphakathi kuya kokuqina kanye nokwelashwa okujwayelekile |
| 31 | Bylvay | i-odevixibat | 7/20/2021 | Ukwelapha pruritus |
| 30 | I-Rezurock | belumosudil | 7/16/2021 | Ukwelapha isifo esingelapheki sokuxhunyelelwa ngokumelene nosokhaya ngemva kokwehluleka okungenani kwemigqa emibili yangaphambili yokwelashwa kwesistimu |
| 29 | fexidazole | fexidazole | 7/16/2021 | Ukwelapha i-trypanosomiasis yabantu base-Afrika ebangelwa i-parasite i-Trypanosoma brucei gambinse |
| 28 | I-Kerendia | finerenone | 7/9/2021 | Ukunciphisa ubungozi bezinkinga zezinso nezenhliziyo ezifweni ezingapheli ezihambisana nesifo sikashukela sohlobo 2 |
| 27 | I-Rylaze | i-asparaginase erwinia chrysanthemi (i-recombinant) -rywn | 6/30/2021 | Ukwelapha i-acute lymphoblastic leukemia kanye ne-lymphoblastic lymphoma ezigulini ezingazwani nemikhiqizo ye-asparaginase ephuma ku-E. coli, njengengxenye yohlu lwemithi yokwelapha ngamakhemikhali. |
| Isitatimende sephephandaba | ||||
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | Ukwelapha isifo i-Alzheimer's |
| Isitatimende sephephandaba | ||||
| 25 | I-Brexafemme | ibrexafuningerp | 6/1/2021 | Ukwelapha i-vulvovaginal candidiasis |
| 24 | I-Lybalvi | i-olanzapine ne-samidorphan | 5/28/2021 | Ukwelapha i-schizophrenia kanye nezici ezithile ze-bipolar I disorder |
| 23 | Truseltiq | i-infigratinib | 5/28/2021 | Ukwelapha i-cholangiocarcinoma onesifo esihlangabezana nemibandela ethile |
| 22 | I-Lumakras | sotorasib | 5/28/2021 | Ukwelapha izinhlobo zomdlavuza wamaphaphu ongewona omncane |
| Isitatimende sephephandaba | ||||
| 21 | I-Pylarify | i-piflufolastat F18 | 5/26/2021 | Ukuhlonza izilonda ze-prostate-specific membrane-antigen kumdlavuza wendlala yesinye |
| 20 | I-Rybrevant | amivantamab-vmjw | 5/21/2021 | Ukwelapha isethi yomdlavuza wamaphaphu weseli ongewona omncane |
| Isitatimende sephephandaba | ||||
| 19 | Empaveli | i-pegcetacoplan | 5/14/2021 | Ukwelapha i-paroxysmal nocturnal hemoglobinuria |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | Ukwelapha izinhlobo ezithile ze-B-cell lymphoma enkulu ebuyele emuva noma ephikisayo |
| 17 | I-Jemperli | dostarlimab-gxly | 4/22/2021 | Ukwelapha umdlavuza we-endometrial |
| Isitatimende sephephandaba | ||||
| 16 | I-Nexttellis | drospirenone futhi estetrol | 4/15/2021 | Ukuvimbela ukukhulelwa |
| 15 | Qelbree | i-viloxazine | 4/2/2021 | Ukwelapha i-attention deficit hyperactivity disorder |
| 14 | I-Zegalogue | i-dasiglucagon | 3/22/2021 | Ukwelapha i-hypoglycemia enzima |
| 13 | I-Ponvory | ponesimod | 3/18/2021 | Ukwelapha izinhlobo ezibuyela emuva ze-multiple sclerosis |
| 12 | I-Fotivda | tivozanib | 3/10/2021 | Ukwelapha i-renal cell carcinoma |
| 11 | I-Azstarys | i-serdexmethylphenidate kanye | 3/2/2021 | Ukwelapha i-attention deficit hyperactivity disorder |
| i-dexmethylphenidate | ||||
| 10 | Pepaxto | i-melphalan flufenamide | 2/26/2021 | Ukwelapha i-myeloma eminingi ebuyele emuva noma ephikisayo |
| 9 | Nulibry | i-fosdenopterine | 2/26/2021 | Ukuze kuncishiswe ingozi yokufa kokuntuleka kwe-molybdenum cofactor Uhlobo A |
| Isitatimende sephephandaba | ||||
| 8 | Amamondi 45 | casimersen | 2/25/2021 | Ukwelapha i-Duchenne muscular dystrophy |
| Isitatimende sephephandaba | ||||
| 7 | Cosela | trilacicilib | 2/12/2021 | Ukunciphisa i-chemotherapy-induced myelosuppression kumdlavuza omncane wamaphaphu weseli |
| Isitatimende sephephandaba | ||||
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | Ukwelapha i-homozygous yomndeni hypercholesterolemia |
| 5 | Ukoniq | umbralisib | 2/5/2021 | Ukwelapha i-marginal zone lymphoma kanye ne-follicular lymphoma |
| 4 | I-Tepmetko | ithepotinib | 2/3/2021 | Ukwelapha umdlavuza wamaphaphu ongewona omncane |
| 3 | Lupkynis | i-voclosporin | 1/22/2021 | Ukwelapha i-lupus nephritis |
| Isivivinyo Sezidakamizwa Isifinyezo | ||||
| 2 | Cabenuva | i-cabotegravir ne-rilpivirine (ihlanganiswe ndawonye) | 1/21/2021 | Ukwelapha i-HIV |
| Isitatimende sephephandaba | ||||
| Isivivinyo Sezidakamizwa Isifinyezo | ||||
| 1 | I-Verquvo | i-vericiguat | 1/19/2021 | Ukunciphisa ingozi yokufa kwenhliziyo nemithambo yegazi kanye nokulaliswa esibhedlela ngenxa yokuhluleka kwenhliziyo okungapheli |
| Isivivinyo Sezidakamizwa Isifinyezo |
Uhlu "lokusetshenziswa olugunyazwe yi-FDA" kule webhusayithi okwezinjongo zokwethula kuphela. Ukuze ubone izimo zokusetshenziswa ezigunyazwe i-FDA [isb, izinkomba, abantu, uhlobo/imithi yomthamo] kumkhiqizo ngamunye wale mikhiqizo, bona Ulwazi Lwakamuva Olugunyazwe I-FDA Lokunquma.
Cashula kuwebhusayithi ye-FDA:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
Isikhathi sokuthumela: Sep-27-2021