Boqapi bo tsamaisa tsoelopele.Ha ho tluoa boqaping ba nts'etsopele ea litlhare tse ncha le lihlahisoa tsa baeloji ea kalafo, Setsi sa FDA sa Tlhahlobo le Lipatlisiso tsa Lithethefatsi (CDER) se ts'ehetsa indasteri ea meriana mohatong o mong le o mong oa ts'ebetso.Ka kutloisiso ea eona ea mahlale a sebelisitsoeng ho theha lihlahisoa tse ncha, liteko le lits'ebetso tsa tlhahiso, le mafu le maemo ao lihlahisoa tse ncha li etselitsoeng ho alafa, CDER e fana ka likeletso tsa mahlale le tsa taolo tse hlokahalang ho tlisa liphekolo tse ncha 'marakeng.
Ho fumaneha ha meriana e mecha le lihlahisoa tsa likokoana-hloko hangata ho bolela mekhoa e mecha ea phekolo bakeng sa bakuli le tsoelo-pele ea tlhokomelo ea bophelo bakeng sa sechaba sa Amerika.Ka lebaka lena, CDER e ts'ehetsa boiqapelo 'me e bapala karolo ea bohlokoa ho thusa ho ntšetsa pele nts'etsopele ea lithethefatsi tse ncha.
Selemo se seng le se seng, CDER e amohela mefuta e mengata e fapaneng ea litlhare tse ncha le lihlahisoa tsa baeloji:
1. Tse ling tsa lihlahisoa tsena ke lihlahisoa tse ncha tseo ho seng mohla li kileng tsa sebelisoa ho tsa bongaka.Ka tlase ke lethathamo la mekhatlo e mecha ea limolek'hule le lihlahisoa tse ncha tsa kalafo tse amohetsoeng ke CDER ka 2021. Lethathamo lena ha le na liente, lihlahisoa tse sa pheleng hantle, mali le lihlahisoa tsa mali, tse tsoang ho plasma, cellular le gene therapy kapa lihlahisoa tse ling tse amohetsoeng ka 2021 Setsi sa Tlhahlobo le Lipatlisiso tsa Biologics.
2. Tse ling li tšoana, kapa li amana le lihlahisoa tse amohetsoeng pele, 'me li tla qothisana lehlokoa le lihlahisoa tseo 'marakeng.Sheba Drugs@FDA bakeng sa tlhahisoleseling mabapi le litlhare tsohle tse lumelletsoeng tsa CDER le lihlahisoa tsa baeloji.
Lithethefatsi tse ling li khetholloa e le mekhatlo e mecha ea limolek'hule ("NMEs") molemong oa tlhahlobo ea FDA.Bongata ba lihlahisoa tsena li na le likarolo tse sebetsang tse so amoheloeng ke FDA nakong e fetileng, e ka ba motsoako o le mong oa moriana kapa e le karolo ea motsoako oa sehlahisoa;hangata lihlahisoa tsena li fana ka liphekolo tse ncha tsa bohlokoa ho bakuli.Lithethefatsi tse ling li khetholloa e le li-NME bakeng sa merero ea tsamaiso, empa leha ho le joalo li na le likarolo tse sebetsang tse amanang haufi-ufi le lihlopha tse sebetsang lihlahisoa tse kileng tsa amoheloa ke FDA.Mohlala, CDER e hlopha lihlahisoa tsa baeloji tse rometsoeng kopong tlas'a karolo ea 351 (a) ea Molao oa Ts'ebeletso ea Bophelo bo Botle e le li-NME molemong oa tlhahlobo ea FDA, ho sa tsotelehe hore na Setsi se kile sa amohela karolo e amanang le sehlahisoa se seng.Khethollo ea FDA ea sethethefatsi e le "NME" molemong oa tlhahlobo e fapane le qeto ea FDA ea hore na sehlahisoa sa lithethefatsi ke "setsi se secha sa lik'hemik'hale" kapa "NCE" ho latela moelelo oa Federal Food, Drug, and Cosmetic Act.
| Che. | Lebitso la Lithethefatsi | Motsoako o sebetsang | Letsatsi la Tumello | Tšebeliso e amohetsoeng ke FDA ka letsatsi la tumello * |
| 37 | Exkivity | mobocertinib | 9/15/2021 | Ho alafa mofetše oa matšoafo oa sele e tsoetseng pele kapa oa metastatic oo e seng o monyane ka epidermal growth factor receptor exon 20 insertion liphetoho |
| 36 | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | Ho phekola boemo bo bokhuts'oane ka lebaka la tlhahiso e sa lekaneng ea "endogenous growth hormone". |
| 35 | Korsuva | difelikefalin | 8/23/2021 | Ho phekola pruritus e leka-lekaneng ho isa ho e matla e amanang le lefu le sa foleng la liphio lichabeng tse itseng |
| 34 | Welireg | belzutifan | 8/13/2021 | Ho phekola lefu la von Hippel-Lindau tlas'a maemo a itseng |
| 33 | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | Ho alafa lefu la Pompe le qalang morao |
| Tsebiso ea boralitaba | ||||
| 32 | Saphnelo | anifrolumab-fnia | 7/30/2021 | Ho alafa systemic lupus erythematousus e itekanetseng ho isa ho e matla mmoho le kalafo e tlwaelehileng |
| 31 | Bylvay | odevixibat | 7/20/2021 | Ho phekola ho hlohlona |
| 30 | Rezurock | belumosudil | 7/16/2021 | Ho alafa lefu le sa foleng la graft-vers-host kamora ho hloleha ha bonyane mela e 'meli ea pele ea systemic therapy |
| 29 | fexidazole | fexidazole | 7/16/2021 | Ho phekola trypanosomiasis ea batho ea Afrika e bakoang ke kokoana-hloko ea Trypanosoma brucei gambiense |
| 28 | Kerendia | finerenone | 7/9/2021 | Ho fokotsa kotsi ea mathata a liphio le pelo ho lefu la liphio le sa foleng le amanang le lefu la tsoekere la mofuta oa 2 |
| 27 | Rylaze | asparaginase erwinia chrysanthemi (recombinant) -rywn | 6/30/2021 | Ho phekola acute lymphoblastic leukemia le lymphoblastic lymphoma ho bakuli ba alejiki ho lihlahisoa tsa asparaginase tse tsoang ho E. coli, e le karolo ea mokhoa oa phekolo ea lik'hemik'hale. |
| Tsebiso ea boralitaba | ||||
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | Ho phekola lefu la Alzheimer |
| Tsebiso ea boralitaba | ||||
| 25 | Brexafemme | ibrexafungerp | 6/1/2021 | Ho phekola vulvovaginal candidiasis |
| 24 | Lybalvi | olanzapine le samidorphan | 5/28/2021 | Ho phekola schizophrenia le likarolo tse ling tsa lefu la ho ferekana kelellong |
| 23 | Truseltiq | Infigratinib | 5/28/2021 | Ho phekola cholangiocarcinoma eo lefu la eona le finyellang litekanyetso tse itseng |
| 22 | Lumakras | sotorasib | 5/28/2021 | Ho phekola mefuta e meng ea mofetše oa matšoafo oa sele e seng nyane |
| Tsebiso ea boralitaba | ||||
| 21 | Pylarify | piflufolastat F18 | 5/26/2021 | Ho tsebahatsa maqeba a antigen-positive a prostate-specific membrane mofetšeng oa senya |
| 20 | Rybrevant | amivantamab-vmjw | 5/21/2021 | Ho phekola mofets'e oa mofets'e o seng nyane oa sele ea matšoafo |
| Tsebiso ea boralitaba | ||||
| 19 | Empaveli | pegcetacoplan | 5/14/2021 | Ho phekola paroxysmal nocturnal hemoglobinuria |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | Ho alafa mefuta e itseng ea ho khutlela morao kapa ho refractory e kholo ea B-cell lymphoma |
| 17 | Jemperli | dostarlimab-gxly | 4/22/2021 | Ho phekola kankere ea endometrial |
| Tsebiso ea boralitaba | ||||
| 16 | Nextstellis | drospirenone le estetrol | 4/15/2021 | Ho thibela bokhachane |
| 15 | Qelbree | viloxazine | 4/2/2021 | Ho alafa kgaello ya kgatello ya maikutlo |
| 14 | Zegalogue | dasiglucagon | 3/22/2021 | Ho phekola hypoglycemia e matla |
| 13 | Ponvory | ponesimod | 3/18/2021 | Ho phekola mefuta e khutlelang morao ea multiple sclerosis |
| 12 | Fotivda | tivozanib | 3/10/2021 | Ho phekola renal cell carcinoma |
| 11 | Azstarys | serdexmethylphenidate le | 3/2/2021 | Ho alafa kgaello ya kgatello ya maikutlo |
| dexmethylphenidate | ||||
| 10 | Pepaxto | melphalan flufenamide | 2/26/2021 | Ho phekola ho khutlela morao kapa ho hanyetsa multiple myeloma |
| 9 | Nulibry | fosdenopterine | 2/26/2021 | Ho fokotsa kotsi ea ho shoa ha molybdenum cofactor Type A |
| Tsebiso ea boralitaba | ||||
| 8 | Li-Amondys 45 | casimersen | 2/25/2021 | Ho phekola Duchenne muscular dystrophy |
| Tsebiso ea boralitaba | ||||
| 7 | Cosela | trilacicilib | 2/12/2021 | Ho fokotsa khatello ea myelosuppression e bakoang ke chemotherapy ho mofetše o monyane oa lisele tsa matšoafo |
| Tsebiso ea boralitaba | ||||
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | Ho phekola hypercholesterolemia ea malapa homozygous |
| 5 | Ukoniq | seboko | 2/5/2021 | Ho phekola marginal zone lymphoma le follicular lymphoma |
| 4 | Tepmetko | tepotinib | 2/3/2021 | Ho alafa mofetše oa matšoafo oa sele e seng nyane |
| 3 | Lupkynis | Voclosporin | 1/22/2021 | Ho phekola lupus nephritis |
| Liteko tsa Lithethefatsi Snapshot | ||||
| 2 | Cabenuva | cabotegravir le rilpivirine (li phuthetsoe hammoho) | 1/21/2021 | Ho alafa HIV |
| Tsebiso ea boralitaba | ||||
| Liteko tsa Lithethefatsi Snapshot | ||||
| 1 | Verquvo | verciguat | 1/19/2021 | Ho fokotsa kotsi ea lefu la pelo le ho kena sepetlele bakeng sa ho hloleha ha pelo ho sa foleng |
| Liteko tsa Lithethefatsi Snapshot |
"Tsebeliso e amohetsoeng ke FDA" e thathamisitsoeng sebakeng sena sa Marang-rang ke molemong oa tlhahiso feela.Ho bona dipehelo tse dumelletsweng ke FDA tsa tshebediso [mohlala, matshwao,(ba)ahi,(ba)(ba)api,(di)regine ya ho noa bakeng sa se seng le se seng sa dihlahiswa tsena, bona Boitsebiso ba moraorao bo dumelletsweng ke FDA.
Qolla ho tsoa webosaeteng ea FDA:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
Nako ea poso: Sep-27-2021