2021 FDA Ogolaanshaha Dawooyinka Cusub 1Q-3Q

Hal-abuurnimadu waxay horseedaa horumarka.Marka ay timaaddo hal-abuurnimada horumarinta dawooyinka cusub iyo alaabada bayoolojiga lagu dabiibo, Xarunta Qiimaynta iyo Cilmi-baadhista ee FDA (CDER) waxay taageertaa warshadaha dawooyinka tallaabo kasta oo habka.Iyada oo la fahamsan yahay sayniska loo isticmaalo in lagu abuuro badeecooyin cusub, tijaabinta iyo hababka wax soo saarka, iyo cudurrada iyo xaaladaha alaabta cusub ee loogu talagalay in lagu daweeyo, CDER waxay bixisaa talo cilmiyeed iyo sharciyeed oo loo baahan yahay si loo keeno daawaynta cusub suuqa.
Helitaanka dawooyin cusub iyo alaabada noolaha waxay inta badan ka dhigan tahay ikhtiyaarka daawaynta cusub ee bukaanka iyo horumarka daryeelka caafimaadka ee dadweynaha Maraykanka.Sababtan awgeed, CDER waxay taageertaa hal-abuurnimada waxayna ka ciyaartaa door muhiim ah inay gacan ka geysato horumarinta daroogada cusub.
Sannad kasta, CDER waxay ansixisay noocyo badan oo daawooyin cusub ah iyo alaabada noolaha:
1. Qaar ka mid ah alaabooyinkan ayaa ah badeecooyin cusub oo cusub oo aan waligood loo isticmaalin waxqabadka caafimaadka.Hoos waxaa ah liisaska unugyada unugyada unugyada cusub iyo alaabada cusub ee daweynta noole ee ay ansixisay CDER 2021. Liiskaan kuma jiro tallaalo, alaabada xasaasiyadda, dhiiga iyo badeecooyinka dhiiga, waxyaalaha balaasmaha ka soo baxa, unugyada iyo alaabada daaweynta hidda-wadaha, ama alaabada kale ee la ansixiyay 2021 Xarunta Qiimaynta Bayolojiga iyo Cilmi-baarista.
2. Kuwo kale waxay la mid yihiin, ama la xidhiidha, badeecooyin hore loo ansixiyay, waxayna kula tartami doonaan alaabtaas suuqa.Ka eeg Drugs@FDA macluumaadka ku saabsan dhammaan dawooyinka CDER-ka la ansixiyay iyo alaabta noolaha.
Daawooyinka qaarkood ayaa loo kala saaray inay yihiin unugyo unugyo cusub ah ("NMEs") ujeedooyinka dib u eegista FDA.Qaar badan oo ka mid ah badeecooyinkan waxay ka kooban yihiin qaybo firfircoon oo aanay FDA hore u ansixin, ha ahaato hal daroogo ama qayb ka mid ah alaabta la isku daray;Alaabooyinkan ayaa had iyo jeer bixiya daawayn cusub oo muhiim u ah bukaanka.Daawooyinka qaarkood waxaa lagu sifeeyaa NMEs ujeeddooyin maamuleed, laakiin si kastaba ha ahaatee waxaa ku jira qaybo firfircoon oo si dhow ula xidhiidha qaybaha firfircoon ee alaabooyinka ay hore u ansixisay FDA.Tusaale ahaan, CDER waxay u kala saartaa alaabada noolaha ee lagu soo gudbiyay codsiga hoos yimaada qaybta 351 (a) ee Sharciga Adeegga Caafimaadka Dadweynaha inay yihiin NMEs ujeeddooyinka dib u eegista FDA, iyadoon loo eegin haddii Wakaaladdu ay hore u ansixisay noole firfircoon oo la xidhiidha badeecad kala duwan.Kala soocida FDA ee daawada sida "NME" ee ujeedooyinka dib u eegista ayaa ka duwan go'aaminta FDA ee haddii badeecada dawooyinka ay tahay "qeyb kiimiko cusub" ama "NCE" oo ku dhex jira macnaha Sharciga Cunnada, Dawooyinka, iyo Isqurxinta ee Federaalka.

Maya Magaca Dawada Walxaha firfircoon Taariikhda Ansixinta Isticmaalka FDA-ansixisay taariikhda la ansixiyay*
37 Kacsi mobocertinib 9/15/2021 Si loo daweeyo kansarka sanbabada unug yar oo aan unug-yarayn oo maxalli ah ama metastatic leh oo leh is-beddelka gelinta gelinta receptor factor exon 20
36 Skytrofa lonapegsomatropin-tcgd 8/25/2021 Si loo daweeyo dherer gaaban sababtoo ah dheecaanka aan ku filnayn ee hormoonka koritaanka endogenous
35 Korsuva difelikefalin 8/23/2021 Si loo daweeyo cuncun dhexdhexaad-ilaa daran oo la xidhiidha cudurrada kelyaha ee daba-dheeraada ee dadka qaarkood
34 Welireg belzutifan 8/13/2021 Si loo daweeyo cudurka von Hippel-Lindau xaalado gaar ah
33 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 Si loo daweeyo cudurka Pompe oo soo daahay
War-saxaafadeed
32 Saphnelo anifrolumab-fnia 7/30/2021 Si loo daweeyo lupus erythematusus nidaamsan dhexdhexaad-ilaa daran oo ay la socoto daaweynta caadiga ah
31 Bylvay odevixibat 7/20/2021 Si loo daweeyo cuncun
30 Rezurock belumosudil 7/16/2021 Si loo daweeyo cudur daba-dheeraada-iska-horjeeda-ka-hortagga ka dib guul-darrida ugu yaraan laba khad oo hore oo daawaynta habaysan
29 fexinidazole fexinidazole 7/16/2021 Si loo daweeyo trypanosomiasis aadanaha ee Afrikaanka ah ee uu keeno dulin-ka Trypanosoma brucei gambiense
28 Kerendia finerenone 7/9/2021 Si loo yareeyo khatarta kalyaha iyo dhibaatooyinka wadnaha ee cudurrada kelyaha ee joogtada ah ee la xidhiidha nooca 2aad ee sonkorowga
27 Rylaze asparaginase erwinia chrysanthemi (recombinant) -rywn 6/30/2021 Si loo daweeyo leukemia ba'an iyo lymphoblastic lymphoma ee bukaanada xasaasiyadda ka leh E. koli-ku-soo-saar alaabada asparaginase, oo qayb ka ah daaweynta kemotherabi
War-saxaafadeed
26 Aduhelm aducanumab-avwa 6/7/2021 Si loo daweeyo cudurka Alzheimers
War-saxaafadeed
25 Brexafemme ibrexafungerp 6/1/2021 Si loo daweeyo candidiasis vulvovaginal
24 Lybalvi olanzapine iyo samidorphan 5/28/2021 Si loo daweeyo schizophrenia iyo qaybo ka mid ah xanuunka laba-cirifoodka
23 Truseltik infigratinib 5/28/2021 Si loo daweeyo cholangiocarcinoma kaas oo cudurkiisu buuxiyey shuruudaha qaarkood
22 Lumakras sotorasib 5/28/2021 Si loo daweeyo noocyada kansarka sambabada unugyada aan yarayn
War-saxaafadeed
21 Pylarify piflufolastat F 18 5/26/2021 Si loo aqoonsado xuubka qanjirka 'prostate' gaar ah nabarrada antigen-positive ee kansarka qanjirka 'prostate'
20 Rybrevant amivantamab-vmjw 5/21/2021 Si loo daweeyo qayb ka mid ah kansarka sambabada unugyada aan yarayn
War-saxaafadeed
19 Empaveli pegcetacoplan 5/14/2021 Si loo daaweeyo haemoglobinuria habeenkii paroxysmal
18 Zynlonta loncastuximab tesirine-lpyl 4/23/2021 Si loo daaweeyo qaar ka mid ah noocyada soo noqnoqda ama soo noqnoqda ee weyn ee B-cell lymfoma
17 Jemperli dostarlimab-gxly 4/22/2021 Si loo daweeyo kansarka endometrial
War-saxaafadeed
16 Nextstellis drospirenone iyo estetrol 4/15/2021 Si looga hortago uurka
15 Qelbree Viloxazine 4/2/2021 Si loo daaweeyo feejignaanta yaraanta firfircoonida
14 Zegalogue dasiglucagon 3/22/2021 Si loo daweeyo hypoglycemia daran
13 Ponvory ponesimod 3/18/2021 Si loo daweeyo noocyada soo noqnoqda ee sclerosis badan
12 Fotivda tivozanib 3/10/2021 Si loo daweeyo kansarka unugyada kelyaha
11 Azstarys Serdexmethylphenidate iyo 3/2/2021 Si loo daaweeyo feejignaanta yaraanta firfircoonida
dexmethylphenidate
10 Pepaxto melphalan flufenamide 2/26/2021 Si loo daweeyo soo laabashada myeloma badan oo soo noqnoqda
9 Nulibry fosdenopterin 2/26/2021 Si loo yareeyo khatarta dhimashada molybdenum cofactor deficiency Nooca A
War-saxaafadeed
8 Amondys 45 casimersen 2/25/2021 Si loo daweeyo Duchenne dystrophy muruqa
War-saxaafadeed
7 Cosela trilacicilib 2/12/2021 Si loo yareeyo daaweynta kiimoterabiga ay keentay myelosuppression ee kansarka sambabada unugyada yaryar
War-saxaafadeed
6 Evkeeza evinacumab-dgnb 2/11/2021 Si loo daaweeyo homozygous familial hypercholesterolemia
5 Ukoniq umbralisib 2/5/2021 Si loo daweeyo lymphoma aagga margin iyo follicular lymphoma
4 Tepmetko tepotinib 2/3/2021 Si loo daweeyo kansarka sambabada unugyada aan yareyn
3 Lupkynis Voclosporin 1/22/2021 Si loo daweeyo lupus nephritis
Sawirka Tijaabada Maandooriyaha
2 Cabenuva cabotegravir iyo rilpivirine (la baakadeeyay) 1/21/2021 Si loo daweeyo HIV
War-saxaafadeed
Sawirka Tijaabada Maandooriyaha
1 Verquvo vericiguat 1/19/2021 Si loo yareeyo khatarta dhimashada wadnaha iyo xididada iyo isbitaal dhigista wadna xanuunka joogtada ah
Sawirka Tijaabada Maandooriyaha

 

Liiska ku qoran "Isticmaalka FDA-ansixisay" ee ku yaal boggan waxa loogu talagalay ujeeddooyin soo jeedin oo keliya.Si aad u aragto shuruudaha isticmaalka ee FDA-ansixisay [tusaale, tilmaan(yaal), dad (dadka), habka qiyaasta (-yada)] mid kasta oo ka mid ah alaabooyinkan, eeg macluumaadka daawaynta ee ay FDA ogolaatay ee ugu dambeysay.
Ka soo xigtay website FDA:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021


Waqtiga post: Seb-27-2021