FDA2022年上半年批准新药西安万隆制药股份有限责任公司王震2022-8-13第一页,共三十二页。第一页,共三十二页。2022上半年FDA批准的新药第二页,共三十二页。第二页,共三十二页。2022上半年FDA批准的新药第三页,共三十二页。第三页,共三十二页。2022上半年FDA批准的新药11普卡那肽普卡那肽Trulance(Plecanatide)Trulance(Plecanatide)片片22盐酸维拉盐酸维拉Parsabiv(etelcalcetide)Parsabiv(etelcalcetide)注射液注射液33地夫可特地夫可特EmflazaEmflaza((DeflazacortDeflazacort)片)片44罗芦单抗罗芦单抗SILIQSILIQ((brodalumabbrodalumab)注射液)注射液55特罗司他乙酯特罗司他乙酯XERMELOXERMELO((TelotristatethylTelotristatethyl)片)片66瑞柏司可里布瑞柏司可里布KisqaliKisqali((RibociclibRibociclib)片)片77沙芬酰胺沙芬酰胺XadagoXadago((SafinamideSafinamide)片)片88SYMPROICSYMPROIC((NaldemedineNaldemedine)片)片99阿维鲁单抗阿维鲁单抗BAVENCIOBAVENCIO((AvelumabAvelumab)注射液)注射液1010尼拉帕尼尼拉帕尼ZejulaZejula(Niraparib,MK-4827(Niraparib,MK-4827)胶囊)胶囊1111OcrevusOcrevus((OcrelizumabOcrelizumab)注射剂)注射剂1212DUPIXENTDUPIXENT((DupilumabDupilumab)注射剂)注射剂第四页,共三十二页。第四页,共三十二页。2022上半年FDA批准的新药1313氘代丁苯那嗪氘代丁苯那嗪AustedoAustedo((DeutetrabenazineDeutetrabenazine)片)片1414缬苯那嗪缬苯那嗪IngrezzaIngrezza((ValbenazineValbenazine)胶囊)胶囊1515米哚妥林米哚妥林RydaptRydapt((MidostaurinMidostaurin)胶囊)胶囊1616TymlosTymlos((AbaloparatideAbaloparatide)注射剂)注射剂1717布吉他滨布吉他滨AlunbrigAlunbrig((BrigatinibBrigatinib)片)片1818依达拉奉依达拉奉RadicavaRadicava((EdaravoneEdaravone)大输液)大输液1919ImfinziImfinzi((durvalumabdurvalumab)注射液)注射液2020单抗单抗Kevzara(sarilumab)Kevzara(sarilumab)注射液注射液2121德拉沙星德拉沙星BaxdelaBaxdela((delafloxacindelafloxacin)片或冻干粉)片或冻干粉2222贝曲沙班贝曲沙班BevyxxaBevyxxa((BetrixabanBetrixaban)胶囊)胶囊2323来那替尼来那替尼NeratinibNeratinib片片2424第五页,共三十二页。第五页,共三十二页。1.消化系统用药普卡那肽Trulance(Plecanatide)片美国FDA批准Trulance为慢性...