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2017年FDA批准新药名单

已有 2349 次阅读 2017-5-18 09:41 |个人分类:新药动态|系统分类:博客资讯|关键词:FDA,新药名单,2017

2017FDA批准新药名单

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FDA官网http://www.fda.org)2017年5月12日提供的最新公布结果,截止2017年5月5日,FDA已经批准了20种新药,约占2016年FDA批准新药数量(22种)的90%。2011-2017年5月5日FDA批准新药数量变化见图1所示。

1  FDA2011-2017年批准新药数量变化

2017年以来(截止2017年5月5日)FDA批准新药名单见表1。

1  2017FDA批准新药一览表

No.Drug
Name
Active IngredientApproval DateFDA-approved use on approval date
20.Radicavaedaravone5/5/20017To treat patients with amyotrophic lateral sclerosis (ALS)
Press Release
19.Imfinzidurvalumab5/1/20017To treat patients with locally advanced or metastatic urothelial carcinoma
Web Post
Drug Trials Snapshot
18.Tymlosabaloparatide4/28/2017To treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies
17.Rydaptmidostaurin4/28/2017To treat acute myeloid leukemia
Press Release
Drug Trials Snapshot
16.Alunbrigbrigatinib4/28/2017To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Drug Trials Snapshot
15.Brineuracerliponase alfa4/27/2017To treat a specific form of Batten disease
Press Release
14.Ingrezzavalbenazine4/11/2017To treat adults with tardive dyskinesia
Press Release  
Drug Trials Snapshot
13.Austedodeutetrabenazine 4/3/2017 For the treatment of chorea associated with Huntington’s disease
Drug Trials Snapshot
12.Ocrevusocrelizumab3/28/2017To treat patients with relapsing and primary progressive forms of multiple sclerosis
Press Release
Drug Trials Snapshot
11.Dupixentdupilumab3/28/2017To treat adults with moderate-to-severe eczema (atopic dermatitis)
Press Release
Drug Trials Snapshot
10.Zejulaniraparib3/27/2017For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers
Press Release
Drug Trials Snapshot
9.Symproic

naldemedine

3/23/2017

For the treatment of opioid-induced constipation
Drug Trials Snapshot

8.Bavencioavelumab3/23/2017To treat metastatic Merkel cell carcinoma
Press Release
Drug Trials Snapshot
7.Xadagosafinamide3/21/2017To treat Parkinson’s disease
Press Release
Drug Trials Snapshot
6.Kisqaliribociclib3/13/2017To treat postmenopausal women with a type of advanced breast cancer
Drug Trials Snapshot
5.Xermelotelotristat ethyl2/28/2017To treat carcinoid syndrome diarrhea
Press Release
Drug Trials Snapshot
4.Siliqbrodalumab2/15/2017To treat adults with moderate-to-severe plaque psoriasis
Press Release
Drug Trials Snapshot
3.Emflazadeflazacort2/9/2017To treat patients age 5 years and older with Duchenne muscular dystrophy (DMD)
Press Release
Drug Trials Snapshot
2.Parsabivetelcalcetide2/8/2017To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis
Drug Trials Snapshot
1.Trulanceplecanatide1/19/2017To treat Chronic Idiopathic Constipation (CIC) in adult patients.
Press Release
Drug Trials Snapshot

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.
更多更新信息请浏览FDA官网。

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm





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