2021 FDA New Drug Approbationes 1Q-3Q

Innovatio progressus repellat.Cum ad innovationem venit in evolutione medicamentorum novarum et productorum biologicorum therapeuticorum, FDA centrum est ad medicamentum Aestimationis et Investigationis (CDER) industriam pharmaceuticam omni gradu processus sustinet.Cum scientia cognitionis eius usus est ad novas res conficiendas, probandas et fabricandas rationes, et morbos et conditiones quae ad novas res tractandas ordinantur, CDER consilium scientificum et moderatorium opus praebet ut novas therapias ad forum deducat.
Prompta nova pharmaca et productorum biologicorum saepe significat novas curationes optiones aegros et progressus sanitatis pro publica Americanorum.Quam ob rem, CDER innovationem sustinet et praecipuum munus agit in adiuvando ad novum medicamento progressum promovendum.
Singulis annis, CDER amplis probat nova pharmaca et productorum biologicorum;
1. Aliquid horum productorum novarum productorum porttitor sunt quae in usu orci numquam adhibiti sunt.Infra enumerationem novarum entitatum hypotheticarum et novorum therapeuticorum biologicorum productorum ab CDER anno 2021 approbatorum. Haec enumeratio vaccina, allergenicos productos, sanguinem et productos sanguineos, derivationes plasmatis, cellulares et genesis productos, vel alios productos in anno 2021 probatos non continet. the Centre for Biologics Aestimation and Research.
2. Alii eaedem sunt quae, vel ad productos antea probatos, et cum illis in foro productis contendent.Vide Medicamenta@FDA ad informationes de omnibus medicamentis probatis CDER et productorum biologicorum.
Quaedam medicamenta ut nova entia hypothetica ("NMEs") collocantur ad recensionem FDA proposita.Multi ex his productis continent moies activas quae antea FDA non approbatae sunt, vel ut medicamentum unum medicamentum vel sicut pars producti complexionis;Haec producta saepe magnas novas therapias aegris praebent.Quaedam medicamenta ut NMEs ad fines administrativos insignita sunt, sed tamen medias activas partes continent, quae proxime ad medietatem activarum rerum in productis antea ab FDA approbatae sunt, continent.Exempli gratia, CDER productos biologicos in applicatione sub sectione 351 (a) in applicatione sub sectione 351 (a) servitutis Publicae NMEs submissas indicat sicut NMEs ad proposita recensionis FDA, cuiuscumque num Agency antea approbaverit relatam medietatem activae in alio facto.FDA divisio medicamenti sicut "NME" ad proposita recensionis distincta ab FDA determinatio num pharmacum productum sit "novum ens chemicum" vel "NCE" in significatione Cibus Foederati, medicamenti et actus cosmetici.

Nec. medicamento nomen Active Ingredient Approbatio Date FDA probatus usus in approbatione date *
37 Exkivity mobocertnib 9/15/2021 Tractare localiter provectum vel metastaticum cellulae non-parvae pulmonis cancri cum factore receptore exon 20 insertis mutationum epidermalium
36 Skytrofa lonapegsomatropin-tcgd 8/25/2021 Tractare statura brevis propter insufficiens secretionem endogenous incrementum hormone
35 Korsuva difelikefalin 8/23/2021 Pruritus cum renibus chronicis in quibusdam populis tractare modica ut- gravi
34 Welireg belzutifan 8/13/2021 De morbo Hippel-Lindau certis conditionibus tractare
33 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 Pompe- rarum nuper morbum tractare
Press Release
32 Saphnelo anifrolumab-fnia 7/30/2021 Lupus erythematousus cum norma justo
31 Bylvay odevixibat 7/20/2021 Pruritus tractare
30 Rezurock belumosudil 7/16/2021 Morbum insitum chronicum versus-hospes curare post defectum duarum saltem linearum priorum de therapia systemica
29 fexinidazole fexinidazole 7/16/2021 Trypanosomiasis Africana humana tractare causatur a parasito Trypanosoma brucei gambiense
28 Kerendia finerenone 7/9/2021 Ad redigendum periculum renis et cordis inpedimenta in morbo longo renum cum type 2 diabete coniungitur
27 Rylaze asparaginasis erwinia chrysanthemi (recombinante) -rywn 6/30/2021 Curare lymphoblasticam leukemia et lymphoblasticam lymphomatum in aegris, qui allergici sunt ad E. productos asparaginas coli derivatos, ut pars disciplinae chemotherapy.
Press Release
26 Aduhelm aducanumab-avwa 6/7/2021 Ad morbos tractare praecox
Press Release
25 Brexafemme ibrexafungerp 6/1/2021 Candidaiasis vulvovaginalis tractare
24 Lybalvi olanzapine et samidorphan 5/28/2021 SCHIZOPHRENIAM tractare et quasdam species bipolaris I inordinationis
23 Truseltiq figuranib 5/28/2021 Curare cholangiocarcinoma cui morbus quidam incidit criteriis
22 Lumakras sotorasib 5/28/2021 Ut tractare genera cancer pulmonis non parvae cellae
Press Release
21 Pylarify piflufolastat F 18 5/26/2021 Ad cognoscendas membranas prostatas speciales antigen-positivas laesiones in cancer prostatae
20 Rybrevant amivantamab-vmjw 5/21/2021 Ad tractandum subset cancer pulmonis celluli non-parvi
Press Release
19 Empaveli pegcetacoplan 5/14/2021 Ad nocturnam hemoglobinuria accessionem tractare
18 Zynlonta loncastuximab tesirine-lpyl 4/23/2021 Tractare quaedam genera lymphoma B-cellula relapsi vel refractorii magni
17 Jemperli dostarlimab-gxly 4/22/2021 Ad cancer tractare endometrial
Press Release
16 Nextstellis drospirenone et estetrol 4/15/2021 Ad ne graviditate
15 Qelbree viloxazine 4/2/2021 Cura defuerit hyperactivity inordinatio tractare
14 Zegalogue dasiglucagon 3/22/2021 Gravibus hypoglycemia tractare
13 Ponvory ponesimod 3/18/2021 Ad formas relapsus plurium sclerosis tractare
12 Fotivda tivozanib 3/10/2021 Ut tractare renum carcinoma
11 Azstarys serdexmethylphenidate et 3/2/2021 Cura defuerit hyperactivity inordinatio tractare
dexmethylphenidate
10 Pepaxto melphalan flufenamide 2/26/2021 Tractare cosmi seu refractory multiple myeloma
9 Nulibry fosdenopterin 2/26/2021 Ad periculum mortalitatis reducendum in molybdeno cofactore defectus Type A
Press Release
8 Amondys 45 casimersen 2/25/2021 Ad dystrophy tractare Duchenne muscularis
Press Release
7 Cosela trilacicilib 2/12/2021 Ad chemotherapy adductus mitigare myelosuppression in parva cellula pulmonis cancer
Press Release
6 Evkeeza evinacumab-dgnb 2/11/2021 Facere homozygous familiaria hypercholesterolemia
5 Ukoniq umbralisib 2/5/2021 Ut zonam marginalem lymphoma et lymphoma follicularis tractare
4 Tepmetko tepotinib 2/3/2021 Ut cancer pulmonis cellula non-parva tractare
3 Lupkynis voclosporin 1/22/2021 Lupus tractare nephritis
Medicamento IUDICIA Snapshot
2 Cabenuva cabotegravir et rilpivirine (co-packaged) 1/21/2021 Ad HIV tractare
Press Release
Medicamento IUDICIA Snapshot
1 Verquvo vericiguat 1/19/2021 Ad mitigandum periculum mortis cardiovascularis et hospitalizationis propter defectum cordis chronica
Medicamento IUDICIA Snapshot

 

Recensentur "FDA-usus probatus" in hac pagina tantum proposita ad exhibendum.Ut videre FDA probatas conditiones usui [exempli, indicationis(s), population(es), regimen dosing(s)] pro unoquoque horum productorum, recentissimas FDA approbatas Informationes praescribens vide.
Cite ex FDA website:--


Post tempus: Sep-27-2021