Innovation ṣe ilọsiwaju ilọsiwaju.Nigba ti o ba de si ĭdàsĭlẹ ninu idagbasoke ti titun oloro ati mba awọn ọja ti ibi, FDA ká Center fun Oògùn Igbelewọn ati Iwadi (CDER) atilẹyin awọn elegbogi ile ise ni gbogbo igbese ti awọn ilana.Pẹlu oye rẹ ti imọ-jinlẹ ti a lo lati ṣẹda awọn ọja tuntun, idanwo ati awọn ilana iṣelọpọ, ati awọn arun ati awọn ipo ti awọn ọja tuntun ti ṣe apẹrẹ lati tọju, CDER pese imọran imọ-jinlẹ ati ilana ti o nilo lati mu awọn itọju tuntun wa si ọja.
Wiwa ti awọn oogun titun ati awọn ọja ti ibi nigbagbogbo tumọ awọn aṣayan itọju titun fun awọn alaisan ati awọn ilọsiwaju ni itọju ilera fun gbogbo eniyan Amẹrika.Fun idi eyi, CDER ṣe atilẹyin imotuntun ati pe o ṣe ipa pataki ninu iranlọwọ lati ṣe ilọsiwaju idagbasoke oogun tuntun.
Ni ọdun kọọkan, CDER fọwọsi ọpọlọpọ awọn oogun titun ati awọn ọja ti ibi:
1. Diẹ ninu awọn ọja wọnyi jẹ awọn ọja tuntun tuntun ti a ko tii lo ni adaṣe ile-iwosan.Ni isalẹ ni atokọ ti awọn ohun elo molikula tuntun ati awọn ọja ibi-itọju titun ti a fọwọsi nipasẹ CDER ni ọdun 2021. Atokọ yii ko ni awọn ajesara, awọn ọja ara korira, ẹjẹ ati awọn ọja ẹjẹ, awọn itọsẹ pilasima, cellular ati awọn ọja itọju Jiini, tabi awọn ọja miiran ti a fọwọsi ni 2021 nipasẹ Ile-iṣẹ fun Igbelewọn Biologics ati Iwadi.
2. Awọn miiran jẹ kanna bii, tabi ti o ni ibatan si, awọn ọja ti a fọwọsi tẹlẹ, ati pe wọn yoo dije pẹlu awọn ọja wọnyẹn ni ọjà.Wo Awọn oogun@FDA fun alaye nipa gbogbo awọn oogun ti CDER ti fọwọsi ati awọn ọja ti ibi.
Awọn oogun kan jẹ ipin bi awọn nkan molikula tuntun (“NMEs”) fun awọn idi ti atunyẹwo FDA.Pupọ ninu awọn ọja wọnyi ni awọn eroja ti nṣiṣe lọwọ ti ko ti fọwọsi nipasẹ FDA tẹlẹ, boya bi oogun eroja kan tabi gẹgẹ bi apakan ti ọja apapọ;Awọn ọja wọnyi nigbagbogbo pese awọn itọju titun pataki fun awọn alaisan.Diẹ ninu awọn oogun jẹ afihan bi awọn NMEs fun awọn idi iṣakoso, ṣugbọn sibẹsibẹ ni awọn agbeka ti nṣiṣe lọwọ ti o ni ibatan pẹkipẹki pẹlu awọn ẹgbẹ ti nṣiṣe lọwọ ninu awọn ọja ti o ti fọwọsi tẹlẹ nipasẹ FDA.Fun apẹẹrẹ, CDER ṣe iyasọtọ awọn ọja ti ibi ti a fi silẹ ninu ohun elo labẹ apakan 351 (a) ti Ofin Iṣẹ Ilera ti Awujọ gẹgẹbi awọn NME fun awọn idi ti atunyẹwo FDA, laibikita boya Ile-ibẹwẹ ti fọwọsi tẹlẹ nkan ti nṣiṣe lọwọ ti o ni ibatan ni ọja ti o yatọ.Ipin FDA ti oogun kan gẹgẹbi “NME” fun awọn idi atunyẹwo jẹ iyatọ si ipinnu FDA ti boya ọja oogun jẹ “ohun elo kemikali tuntun” tabi “NCE” laarin itumọ ti Federal Food, Drug, and Cosmetic Act.
| Rara. | Orúkọ Oògùn | Eroja ti nṣiṣe lọwọ | Ọjọ Ifọwọsi | Lilo FDA-fọwọsi ni ọjọ ifọwọsi * |
| 37 | Exkivity | mobocertinib | 9/15/2021 | Lati tọju ilọsiwaju ti agbegbe tabi akàn ẹdọfóró ti kii-kekere sẹẹli pẹlu epidermal idagba ifosiwewe receptor exon 20 awọn iyipada ifibọ |
| 36 | Skytrofa | lonapegsomatropin-tcgd | 25/8/2021 | Lati ṣe itọju kukuru kukuru nitori yomijade ti ko to ti homonu idagba endogenous |
| 35 | Konsuva | difelikefalin | 8/23/2021 | Lati ṣe itọju irẹwẹsi iwọntunwọnsi si lile ti o ni nkan ṣe pẹlu arun kidinrin onibaje ni awọn olugbe kan |
| 34 | Welireg | belzutifan | 8/13/2021 | Lati tọju arun von Hippel-Lindau labẹ awọn ipo kan |
| 33 | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | Lati toju pẹ-ibẹrẹ arun Pompe |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 32 | Saphnelo | anifrolumab-fnia | 30/7/2021 | Lati tọju iwọntunwọnsi-si àìdá eto-ara lupus erythematusus pẹlu itọju ailera boṣewa |
| 31 | Bylvay | odevixibat | 7/20/2021 | Lati toju pruritus |
| 30 | Rezurock | belumosudil | 16/7/2021 | Lati toju onibaje alọmọ-laisi-ogun arun lẹhin ikuna ti o kere ju laini meji ṣaaju ti itọju ailera eto |
| 29 | fexinidazole | fexinidazole | 16/7/2021 | Lati toju eda eniyan African trypanosomiasis ṣẹlẹ nipasẹ awọn parasite Trypanosoma brucei gambiense |
| 28 | Kerendia | finerenone | 7/9/2021 | Lati dinku eewu kidinrin ati awọn ilolu ọkan ninu arun kidinrin onibaje ti o ni nkan ṣe pẹlu àtọgbẹ iru 2 |
| 27 | Rylaze | asparaginase erwinia chrysanthemi (recombinant) -rywn | 30/6/2021 | Lati ṣe itọju aisan lukimia nla ti lymphoblastic ati lymphoma lymphoblastic ninu awọn alaisan ti o ni inira si awọn ọja asparaginase ti E. coli, gẹgẹbi apakan ti ilana ilana chemotherapy |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | Lati tọju arun Alzheimer |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 25 | Brexafemme | ibrexafungerp | 6/1/2021 | Lati ṣe itọju candidiasis vulvovaginal |
| 24 | Lybalvi | olanzapine ati samidorphan | 28/5/2021 | Lati tọju schizophrenia ati awọn abala kan ti iṣọn-ẹjẹ bipolar I |
| 23 | Truseltik | infigratinib | 28/5/2021 | Lati tọju cholangiocarcinoma ti arun rẹ pade awọn ibeere kan |
| 22 | Lumakras | sotorasib | 28/5/2021 | Lati tọju awọn oriṣi ti akàn ẹdọfóró sẹẹli ti kii ṣe kekere |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 21 | Pylarify | piflufolastat F 18 | 26/5/2021 | Lati ṣe idanimọ prostate-pato membran antigen-rere awọn egbo ninu akàn pirositeti |
| 20 | Rybrevant | amivantamab-vmjw | 21/5/2021 | Lati tọju ipin kan ti akàn ẹdọfóró sẹẹli ti kii ṣe kekere |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 19 | Empaveli | pegcetacoplan | 5/14/2021 | Lati tọju haemoglobinuria nocturnal paroxysmal |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | Lati tọju awọn iru kan ti ifasẹyin tabi ti o tobi ti lymphoma B-cell refractory |
| 17 | Jemperli | dostarlimab-gxly | 4/22/2021 | Lati ṣe itọju akàn endometrial |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 16 | Nextstellis | drospirenone ati estetrol | 4/15/2021 | Lati dena oyun |
| 15 | Qelbree | viloxazine | 4/2/2021 | Lati toju aipe akiyesi hyperactivity rudurudu |
| 14 | Zegalogue | dasiglucagon | 22/3/2021 | Lati tọju hypoglycemia nla |
| 13 | Ponvory | ponesimod | 3/18/2021 | Lati tọju awọn fọọmu ifasẹyin ti ọpọ sclerosis |
| 12 | Fotivda | tivozanib | 3/10/2021 | Lati toju kidirin cell carcinoma |
| 11 | Azstarys | serdexmethylphenidate ati | 3/2/2021 | Lati toju aipe akiyesi hyperactivity rudurudu |
| dexmethylphenidate | ||||
| 10 | Pepaxto | melphalan flufenamide | 26/2/2021 | Lati toju ifasẹyin tabi refractory ọpọ myeloma |
| 9 | Nulibry | fosdenopterin | 26/2/2021 | Lati dinku eewu iku ni aipe molybdenum cofactor Type A |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 8 | Amin 45 | casimersen | 25/2/2021 | Lati toju Duchenne dystrophy ti iṣan |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 7 | Kosela | trilacicilib | 2/12/2021 | Lati dinku kimoterapi-induced myelosuppression ni kekere sẹẹli ẹdọfóró akàn |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | Lati tọju hypercholesterolemia familial homozygous |
| 5 | Ukoniq | umbralisib | 2/5/2021 | Lati ṣe itọju linfoma agbegbe alapin ati lymphoma follicular |
| 4 | Tepmetko | tepotinib | 2/3/2021 | Lati tọju akàn ẹdọfóró sẹẹli ti kii ṣe kekere |
| 3 | Lupkynis | voclosporin | 22/1/2021 | Lati ṣe itọju lupus nephritis |
| Aworan Idanwo Oògùn | ||||
| 2 | Cabenuva | cabotegravir ati rilpivirine (ti a kojọpọ) | 21/1/2021 | Lati toju HIV |
| Atẹjade lati ilẹ-iṣẹ irohin | ||||
| Aworan Idanwo Oògùn | ||||
| 1 | Verquvo | vericiguat | 19/1/2021 | Lati dinku eewu iku iku ọkan ati ile-iwosan fun ikuna ọkan onibaje |
| Aworan Idanwo Oògùn |
Awọn akojọ "FDA-fọwọsi lilo" lori oju opo wẹẹbu yii jẹ fun awọn idi igbejade nikan.Lati wo awọn ipo lilo ti FDA-fọwọsi [fun apẹẹrẹ, awọn itọkasi (s), olugbe(s), awọn ilana iwọn lilo (s)] fun ọkọọkan awọn ọja wọnyi, wo Alaye Itọkasi FDA ti o ṣẹṣẹ julọ.
Tọkasi lati oju opo wẹẹbu FDA:https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
Akoko ifiweranṣẹ: Oṣu Kẹsan-27-2021