美国FDA2011年至2014年批准的药品New Molecular Entity Approvals for - 新药热点

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美国FDA2011年至2014年批准的药品New Molecular Entity Approvals for

2014-07-04 12:24:56 来源: 作者: 【大中小】浏览:759次评论:0条

The list below includes the NMEs and BLAs approved by CDER in calendar year 2014.

(The Drug Name link provides full product details, i.e., prescribing information, approval history, and reviews.)

No.

Drug Name

Active Ingredient

Date

What It’s Used For

17.

tedizolid phosphate

6/20/2014

To treat adults with skin infections
Press Release⁶

16.

Jublia⁷

efinaconazole

6/6/2014

Treat mild to moderate onychomycosis (fungal infection)
No Press Release

15.

Dalvance⁸

dalbavancin

5/23/2014

To treat adults with skin infections
Press Release⁹

14.

Entyvio¹⁰

vedolizumab

5/20/2014

To treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease
Press Release¹¹

13.

vorapaxar

5/8/2014

To reduce the risk of heart attacks and stroke in high-risk patients
Press Release¹³

12.

ceritinib

4/29/2014

To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC)
Press Release¹⁵

11.

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