Innovation inofambisa kufambira mberi.Kana zvasvika kune hunyanzvi mukugadzirwa kwemishonga mitsva uye kurapa zvipenyu zvigadzirwa, FDA's Center for Drug Evaluation and Research (CDER) inotsigira indasitiri yemishonga padanho rega rega rekuita.Nekunzwisisa kwayo kwesainzi inoshandiswa kugadzira zvigadzirwa zvitsva, nzira dzekuyedza nekugadzira, uye zvirwere nemamiriro ayo zvigadzirwa zvitsva zvakagadzirirwa kurapa, CDER inopa sainzi uye kuraira zano rinodiwa kuunza marapirwo matsva kumusika.
Kuvepo kwemishonga mitsva uye zvigadzirwa zvebhayoloji zvinowanzoreva nzira nyowani dzekurapa kuvarwere uye kufambira mberi mune zvehutano kuruzhinji rweAmerica.Nechikonzero ichi, CDER inotsigira hunyanzvi uye inoita basa rakakosha mukubatsira kusimudzira kuvandudzwa kwezvinodhaka.
Gore rega rega, CDER inobvumidza kuwanda kwemishonga mitsva uye zvigadzirwa zvebiological:
1. Zvimwe zvezvigadzirwa izvi zvigadzirwa zvitsva zvisati zvamboshandiswa mumakiriniki maitiro.Pazasi pane rondedzero yezvitsva zvemolecular uye zvitsva zvekurapa zvipenyu zvakabvumidzwa neCDER muna 2021. Iyi rondedzero haina mishonga yekudzivirira, allergenic zvigadzirwa, ropa uye zvigadzirwa zveropa, zvinobuda muplasma, cellular uye gene therapy zvigadzirwa, kana zvimwe zvigadzirwa zvakatenderwa muna 2021 by. iyo Center for Biologics Evaluation uye Tsvagiridzo.
2. Zvimwe zvakafanana, kana kuti zvine chekuita nezvigadzirwa zvakambobvumidzwa, uye vachakwikwidzana nezvigadzirwa izvozvo pamusika.Ona Drugs@FDA kuti uwane ruzivo nezvese emishonga inotenderwa neCDER uye zvigadzirwa zvebiological.
Mimwe mishonga inorongedzerwa senhengo nyowani dzemamorekuru ("NMEs") nechinangwa chekuongorora kweFDA.Zvizhinji zvezvigadzirwa izvi zvine zvikamu zvinoshanda zvisina kutenderwa neFDA kare, ingave sechinhu chimwe chemishonga kana sechikamu chemusanganiswa wechigadzirwa;zvigadzirwa izvi zvinowanzopa zvakakosha kurapa kutsva kune varwere.Mimwe mishonga inoratidzirwa seNMEs yezvinangwa zvekutonga, asi zvakadaro ine mitezo inoshanda inoenderana zvakanyanya neaya anoshanda muzvigadzirwa zvakambobvumidzwa neFDA.Semuyenzaniso, CDER inoisa zvigadzirwa zvebhayoloji zvakaunzwa mukunyorera pasi pechikamu 351 (a) chePublic Health Service Act seNMEs nechinangwa chekuongorora kweFDA, zvisinei nekuti Agency yakambobvumidza chikamu chinoshanda mune chimwe chigadzirwa chakasiyana.Kusarudzwa kweFDA kwemushonga se "NME" kwezvinangwa zvekuongorora kwakasiyana kubva kune FDA kutsunga kuti chigadzirwa chemushonga i "new chemical entity" kana "NCE" mukati mezvinoreva Federal Food, Drug, and Cosmetic Act.
| Aihwa. | Zita rezvinodhaka | Active Ingredient | Zuva Rokubvumirwa | FDA-yakatenderwa kushandiswa pazuva rekubvumidzwa * |
| 37 | Exkivity | mobocertinib | 9/15/2021 | Kurapa munharaunda yepamusoro kana metastatic isiri-diki cell kenza yemapapu ine epidermal kukura factor receptor exon 20 kuisa shanduko. |
| 36 | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | Kubata hupfupi nekuda kwekusakwana secretion ye endogenous growth hormone |
| 35 | Korsuva | difelikefalin | 8/23/2021 | Kurapa pakati-kusvika-yakanyanya pruritus yakabatana nechirwere cheitsvo chisingaperi mune vamwe vanhu |
| 34 | Welireg | belzutifan | 8/13/2021 | Kurapa chirwere chevon Hippel-Lindau pasi pemamwe mamiriro |
| 33 | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | Kurapa kunonoka-kutanga Pompe chirwere |
| Press Release | ||||
| 32 | Saphnelo | anifrolumab-fnia | 7/30/2021 | Kurapa zvine mwero-kusvika kuomarara systemic lupus erythematousus pamwe neyakajairwa kurapa |
| 31 | Bylvay | odevixibat | 7/20/2021 | Kurapa pruritus |
| 30 | Rezurock | belumosudil | 7/16/2021 | Kurapa chirwere chisingaperi chegraft-versus-host chirwere mushure mekukundikana kweinenge mbiri mitsetse yekutanga ye systemic therapy |
| 29 | fexidazole | fexidazole | 7/16/2021 | Kurapa vanhu vemuAfrica trypanosomiasis inokonzerwa neparasite Trypanosoma brucei gambiense |
| 28 | Kerendia | finerenone | 7/9/2021 | Kuti uderedze njodzi yeitsvo uye yemoyo matambudziko muchirwere cheitsvo chisingaperi chinosanganiswa nerudzi rwe2 chirwere cheshuga |
| 27 | Rylaze | asparaginase erwinia chrysanthemi (recombinant) -rywn | 6/30/2021 | Kurapa acute lymphoblastic leukemia uye lymphoblastic lymphoma muvarwere vasingawirirani neE. coli-derived asparaginase products, sechikamu chechirongwa chechemotherapy. |
| Press Release | ||||
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | Kurapa chirwere cheAlzheimer |
| Press Release | ||||
| 25 | Brexafemme | ibrexafungerp | 6/1/2021 | Kurapa vulvovaginal candidiasis |
| 24 | Lybalvi | olanzapine uye samidorphan | 5/28/2021 | Kurapa schizophrenia uye zvimwe zvikamu zvebipolar I disorder |
| 23 | Truseltiq | infigratinib | 5/28/2021 | Kurapa cholangiocarcinoma ane chirwere chinosangana nemamwe maitiro |
| 22 | Lumakras | sotorasib | 5/28/2021 | Kurapa marudzi egomarara remapapu asiri diki |
| Press Release | ||||
| 21 | Pylarify | piflufolastat F18 | 5/26/2021 | Kuziva prostate-specific membrane antigen-positive maronda mugomarara reprostate |
| 20 | Rybrevant | amivantamab-vmjw | 5/21/2021 | Kurapa chikamu chegomarara remapapu risiri diki |
| Press Release | ||||
| 19 | Empaveli | pegcetacoplan | 5/14/2021 | Kurapa paroxysmal nocturnal hemoglobinuria |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | Kurapa mamwe marudzi ekudzokororwa kana refractory hombe B-cell lymphoma |
| 17 | Jemperli | dostarlimab-gxly | 4/22/2021 | Kurapa endometrial cancer |
| Press Release | ||||
| 16 | Nextstelles | Estetrol uye drospirenone | 4/15/2021 | Kudzivirira kubata pamuviri |
| 15 | Qelbree | viloxazine | 4/2/2021 | Kurapa kutarisisa kutadza hyperactivity disorder |
| 14 | Zegalogue | dasiglucagon | 3/22/2021 | Kurapa yakanyanya hypoglycemia |
| 13 | Ponvory | ponesimod | 3/18/2021 | Kurapa mafomu ekudzokazve kwemultiple sclerosis |
| 12 | Fotivda | tivozanib | 3/10/2021 | Kurapa renal cell carcinoma |
| 11 | Azstarys | serdexmethylphenidate uye | 3/2/2021 | Kurapa kutarisisa kutadza hyperactivity disorder |
| dexmethylphenidate | ||||
| 10 | Pepaxto | melphalan flufenamide | 2/26/2021 | Kurapa kudzokazve kana kuti refractory multiple myeloma |
| 9 | Nulibry | fosdenopteri | 2/26/2021 | Kudzikisa njodzi yekufa mu molybdenum cofactor kushomeka Type A |
| Press Release | ||||
| 8 | Amondys 45 | casimersen | 2/25/2021 | Kurapa Duchenne muscular dystrophy |
| Press Release | ||||
| 7 | Cosela | trilacicilib | 2/12/2021 | Kudzikamisa chemotherapy-induced myelosuppression mudiki kenza yemapapu |
| Press Release | ||||
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | Kurapa homozygous mhuri hypercholesterolemia |
| 5 | Ukoniq | umbralisib | 2/5/2021 | Kurapa marginal zone lymphoma uye follicular lymphoma |
| 4 | Tepmetko | tepotinib | 2/3/2021 | Kurapa gomarara remapapu risiri diki |
| 3 | Lupkynis | voclosporin | 1/22/2021 | Kurapa lupus nephritis |
| Drug Trials Snapshot | ||||
| 2 | Cabenuva | cabotegravir uye rilpivirine (yakabatanidzwa) | 1/21/2021 | Kurapa HIV |
| Press Release | ||||
| Drug Trials Snapshot | ||||
| 1 | Verquvo | vericiguat | 1/19/2021 | Kudzikamisa njodzi yekufa kwemoyo uye kuchipatara nekuda kwekusagadzikana kwemoyo |
| Drug Trials Snapshot |
Iyo yakanyorwa "FDA-yakatenderwa kushandiswa" pane ino webhusaiti ndeyezvinangwa zvekuratidzira chete.Kuona iyo FDA-yakatenderwa mamiriro ekushandiswa [semuenzaniso, chiratidzo(s), vanhu, dosing regimen(s)] kune chimwe nechimwe chezvigadzirwa izvi, ona ichangoburwa FDA-yakatenderwa Kunyora Ruzivo.
Dzvanya kubva kune FDA webhusaiti:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
Nguva yekutumira: Sep-27-2021