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