Ukuqamba okusha kuqhubekisela phambili inqubekelaphambili.Uma kuziwa emisha ekuthuthukisweni kwemithi emisha kanye nemikhiqizo yebhayoloji yokwelapha, Isikhungo Se-FDA Sokuhlola Nokucwaninga Izidakamizwa (CDER) sisekela imboni yezokwelapha kuzo zonke izinyathelo zenqubo.Ngokuqonda kwayo isayensi esetshenziselwa ukwakha 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 izinketho ezintsha zokwelapha ezigulini 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 kanye nemikhiqizo emisha yokwelapha egunyazwe i-CDER ngo-2021. Lokhu kufakwa ohlwini akuqukethe 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 zamangqamuzana amasha ("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 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" ngaphakathi kwencazelo 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-hormone yokukhula engokwemvelo |
| 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 ukulunywa |
| 30 | I-Rezurock | belumosudil | 7/16/2021 | Ukwelapha isifo esingamahlalakhona 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-positive kumdlavuza wendlala yesinye |
| 20 | I-Rybrevant | amivantamab-vmjw | 5/21/2021 | Ukwelapha isethi yomdlavuza wamaphaphu 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 Type 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 | I-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