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FDA批准Strides Arcolab公司生产仿制氟尿嘧啶注射液

来源:环球医学编译    时间:2012年07月25日    点击数:    5星

7月25日消息 - 环球医学据悉,总部位于班加罗尔的制药公司Strides Arcolab透露,其已获美国食品和药物管理局(FDA)批准,生产用于治疗各种癌症的仿制氟尿嘧啶注射液。

IMS最新公布的数字显示,仿制氟尿嘧啶的美国市场行情超过1千4百万美元。氟尿嘧啶通过干扰制造DNA和RNA的细胞的功能而起效,从而防止癌症的扩散。

Strides Arcolab公司表示,它已获批生产50mg/ml效能的仿制氟尿嘧啶,包装为10ml和20ml的单剂量小瓶,以及2.5g/50ml和5g/100ml的药房大包装。(环球医学)

原文:

Strides Arcolab Receives FDA Approval for Generic Fluorouracil Injection

Bangalore-based pharmaceutical company Strides Arcolab revealed that it has received an approval from the US Food and Drug Administration for the manufacture of its generic Fluorouracil Injection for treating various cancers. 

Recent figures released by IMS reveals that generic Fluorouracil has a market of over $14 million in the United States. Fluorouracil works by interfering in the function of the cells making DNA and RNA, thus preventing the spread of the cancer. 

Strides Arcolab said that it has received approval to manufacture the drug in strengths of 50 mg / ml, packaged in 10 ml and 20 ml single-dose vials and 2.5 g/ 50 ml and 5 g / 100 ml pharmacy bulk packages. 

 

相关链接:http://www.medindia.net/news/strides-arcolab-receives-fda-approval-for-generic-fluorouracil-injection-104363-1.htm

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