2021 FDA Yemeza Ibiyobyabwenge 1Q-3Q

Guhanga udushya bitera imbere.Ku bijyanye no guhanga udushya mu guteza imbere imiti mishya n’ibicuruzwa bivura ibinyabuzima, Ikigo cya FDA gishinzwe gusuzuma no gukora ubushakashatsi (CDER) gishyigikira inganda zimiti kuri buri ntambwe.Hamwe no gusobanukirwa siyanse ikoreshwa mugukora ibicuruzwa bishya, kugerageza no gukora, hamwe nindwara nibintu ibicuruzwa bishya bigenewe kuvura, CDER itanga inama zubumenyi nubuyobozi bukenewe kugirango ubuvuzi bushya bugere ku isoko.
Kuboneka imiti mishya nibicuruzwa byibinyabuzima bisobanura uburyo bushya bwo kuvura abarwayi niterambere ryubuvuzi kubanyamerika.Kubera iyo mpamvu, CDER ishyigikira udushya kandi igira uruhare runini mugufasha guteza imbere ibiyobyabwenge bishya.
Buri mwaka, CDER yemeza imiti myinshi nibinyabuzima:
1. Bimwe muri ibyo bicuruzwa nibicuruzwa bishya bitigeze bikoreshwa mubikorwa byubuvuzi.Hano hepfo urutonde rwibintu bishya bya molekuline nibicuruzwa bishya bivura biologiya byemejwe na CDER mu 2021. Uru rutonde ntirurimo inkingo, ibicuruzwa bya allergique, amaraso n’amaraso, ibikomoka kuri plasma, ibikomoka kuri selile na gene, cyangwa ibindi bicuruzwa byemejwe muri 2021 na Ikigo gishinzwe gusuzuma ibinyabuzima nubushakashatsi.
2. Abandi ni kimwe, cyangwa bifitanye isano, ibicuruzwa byemewe mbere, kandi bazahatanira ibyo bicuruzwa kumasoko.Reba Ibiyobyabwenge @ FDA kugirango umenye amakuru yimiti yose yemewe na CDER nibinyabuzima.
Imiti imwe n'imwe ishyirwa mubintu bishya bya molekile ("NMEs") hagamijwe gusuzuma FDA.Byinshi muri ibyo bicuruzwa birimo ibintu bikora bitemewe na FDA mbere, haba nk'ibiyobyabwenge kimwe cyangwa igice cyibicuruzwa bivanze;ibyo bicuruzwa akenshi bitanga imiti mishya kubarwayi.Ibiyobyabwenge bimwe birangwa na NMEs kubikorwa byubuyobozi, ariko nonese birimo moieties ikora ifitanye isano rya hafi nimikorere ikora mubicuruzwa byemejwe mbere na FDA.Kurugero, CDER ishyira mubikorwa ibinyabuzima byatanzwe mubisabwa munsi yingingo ya 351 (a) y itegeko rigenga serivisi zubuzima rusange nka NMEs hagamijwe gusuzuma FDA, tutitaye ko Ikigo cyabanje kwemeza ibikorwa bifitanye isano nibicuruzwa bitandukanye.Icyiciro cya FDA cyo gushyira ibiyobyabwenge nka "NME" mu rwego rwo gusuzuma biratandukanye n’icyemezo cya FDA cyo kumenya niba ibiyobyabwenge ari "imiti mishya" cyangwa "NCE" mu bisobanuro by’amategeko agenga ibiryo, ibiyobyabwenge, no kwisiga.

Oya. Izina ry'ibiyobyabwenge Ibikoresho bifatika Itariki yo kwemererwa Imikoreshereze yemewe na FDA kumunsi wemejwe *
37 Gukabya mobocertinib 15/9/2021 Kuvura kanseri yateye imbere cyangwa metastatike itari ntoya ya kanseri yibihaha hamwe na epidermal growth factor reseptor exon 20 insertion mutation
36 Skytrofa lonapegsomatropin-tcgd 25/8/2021 Kuvura uburebure buke kubera gusohora kudahagije kwa hormone yo gukura
35 Korsuva difelikefalin 23/8/2021 Kuvura pruritus iringaniye-ikabije ifitanye isano n'indwara zimpyiko zidakira mubantu bamwe
34 Welireg belzutifan 13/8/2021 Kuvura indwara ya Hippel-Lindau mubihe bimwe
33 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 Kuvura indwara ya Pompe itinze
Itangaza makuru
32 Saphnelo anifrolumab-fnia 30/7/2021 Kuvura ibintu biciriritse-bikabije sisitemu ya lupus erythematousus hamwe nubuvuzi busanzwe
31 Bylvay odevixibat 20/7/2021 Kuvura pruritus
30 Rezurock belumosudil 16/7/2021 Kuvura indwara zidakira-zakira-nyuma yo kunanirwa byibura imirongo ibiri ibanza yo kuvura sisitemu
29 fexinidazole fexinidazole 16/7/2021 Kuvura abantu bo muri Afrika trypanosomiasis iterwa na parasite Trypanosoma brucei gambiense
28 Kerendia finerenone 7/9/2021 Kugabanya ibyago byimpyiko numutima byindwara zimpyiko zidakira zifitanye isano na diyabete yo mu bwoko bwa 2
27 Rylaze asparaginase erwinia chrysanthemi (recombinant) -rywn 30/6/2021 Kuvura lymphoblastique ikaze na lymphlastique lymphoma kubarwayi bafite allergie kubicuruzwa bya E. coli bikomoka kuri asparaginase, nkibigize imiti ya chimiotherapie
Itangaza makuru
26 Aduhelm aducanumab-avwa 6/7/2021 Kuvura indwara ya Alzheimer
Itangaza makuru
25 Brexafemme ibrexafungerp 1/6/2021 Kuvura candidiasis ya vulvovaginal
24 Lybalvi olanzapine na samidorphan 28/5/2021 Kuvura sikizofreniya nibintu bimwe na bimwe bya bipolar I.
23 Truseltiq infigratinib 28/5/2021 Kuvura cholangiocarcinoma indwara yayo yujuje ibisabwa
22 Lumakras sotorasib 28/5/2021 Kuvura ubwoko bwa kanseri y'ibihaha itari ntoya
Itangaza makuru
21 Pylarify piflufolastat F 18 26/5/2021 Kumenya prostate yihariye ya antigen-positifike ya kanseri ya prostate
20 Rybrevant amivantamab-vmjw 21/5/2021 Kuvura igice cya kanseri y'ibihaha itari ntoya
Itangaza makuru
19 Empaveli pegcetacoplan 14/5/2021 Kuvura paroxysmal nijoro nijoro hemoglobinuria
18 Zynlonta loncastuximab tesirine-lpyl 23/4/2021 Kuvura ubwoko bumwebumwe bwisubiramo cyangwa buvunagura lymphoma nini
17 Jemperli dostarlimab-gxly 22/4/2021 Kuvura kanseri ya endometinal
Itangaza makuru
16 Ibikurikira drospirenone na estetrol 15/4/2021 Kurinda gusama
15 Qelbree viloxazine 4/2/2021 Kuvura kwitondera defisit hyperactivivi
14 Zegalogue dasiglucagon 22/3/2021 Kuvura hypoglycemia ikabije
13 Ponvory ponesimod 18/3/2021 Kuvura uburyo bwisubiramo bwa sclerose nyinshi
12 Fotivda tivozanib 3/10/2021 Kuvura kanseri yimpyiko
11 Azstarys serdexmethylphenidate na 3/2/2021 Kuvura kwitondera defisit hyperactivivi
dexmethylphenidate
10 Pepaxto melphalan flufenamide 26/2/2021 Kuvura ibyasubiwemo cyangwa byanze bikunze myeloma
9 Nulibry fosdenopterin 26/2/2021 Kugabanya ibyago byo gupfa muri molybdenum cofactor ibura Ubwoko A.
Itangaza makuru
8 Amondys 45 casimersen 25/2/2021 Kuvura Duchenne imitsi ya dystrofiya
Itangaza makuru
7 Cosela trilacicilib 2/12/2021 Kugabanya imiti ya chimiotherapie iterwa na myelosuppression muri kanseri ntoya yibihaha
Itangaza makuru
6 Evkeeza evinacumab-dgnb 2/11/2021 Kuvura homosexous familial hypercholesterolemia
5 Ukoniq umbralisib 2/5/2021 Kuvura lymphoma ya marginal na lymphoma
4 Tepmetko tepotinib 2/3/2021 Kuvura kanseri y'ibihaha itari ntoya
3 Lupkynis rimonabant 1/22/2021 Kuvura lupus nephritis
Ikigeragezo cyibiyobyabwenge Snapshot
2 Cabenuva cabotegravir na rilpivirine (bafatanije) 1/21/2021 Kuvura virusi itera SIDA
Itangaza makuru
Ikigeragezo cyibiyobyabwenge Snapshot
1 Verquvo vericiguat 1/19/2021 Kugabanya ibyago byo gupfa k'umutima n'imitsi no gushyirwa mubitaro kubera kunanirwa k'umutima bidakira
Ikigeragezo cyibiyobyabwenge Snapshot

 

Urutonde "FDA yemewe gukoreshwa" kururu rubuga ni intego yo kwerekana gusa.Kugirango ubone FDA yemewe yo gukoresha [urugero, ibyerekana (s), abaturage (s), uburyo bwo gufata imiti kuri buri gicuruzwa, reba amakuru ya FDA yemewe vuba aha.
Tanga urubuga rwa FDA:https: //www.fda.gov


Igihe cyo kohereza: Nzeri-27-2021