Monday, August 21, 2017

Irinotecan Injection Approved by US FDA in Dec 16, 2011

A China-produced antineoplastic injection has been approved by the U.S. Food and Drug Administration (FDA), becoming the country's first injection category to acquire the approval, the drug producer said Tuesday.

With the approval, the injection, Irinotecan, made by the Jiangsu Hengrui Medicine Co., Ltd., will be allowed on sale in the United States, said Sun Piaoyang, chairman of the company.

According to the written statement released on Tuesday, the FDA issued the approval on Friday local time, making the company the first pharmaceutical manufacturer of China to get injection approval from FDA, Sun said.

The company started research on the injection in 2006, and in July 2010, the FDA assigned a team for a 13-day certification check before the approval was issued.

Established in 1970 and based in the eastern province of Jiangsu, the Shanghai-listed Jiangsu Hengrui Medicine Co., Ltd. is the largest manufacturing base of antineoplastic and stupefacient (http://english.cri.cn/6909/2011/12/20/1461s672409.htm).

[2011-12-20 14:32:15 Xinhua Web Editor: Zhangjin]