Medical network on April 15 - April 13, the national center for drug safety administration drug approval issued "quasi" priority review of publication of the application for drug registration (15) ", to fit the nine priority review of drug registration application and the applicant shall be fair show, fair show period 5. 

 

During the public if there is any discrepancy, please in the center of the drug approval website "information - > priority review of the public - to varieties of priority review of the public" column under dispute. 

 

From the point of application items, the the list of the public, there are two new drug clinical trials, the listing of three new drugs, 4 generics, involving boehringer ingelheim Cain, Beijing science and technology, glaxosmithkline, a proud hundred miles, chengdu rong raw pharmaceutical, hengrui pharmaceutical group, nolato, the Italian pharmaceutical seven companies. 

 

Notable is, fitting into the priority review of four generic drug applications have hengrui pharmaceutical benzene sulfonic suitable atracurium injection, and the meaning of pharmaceutical shiyao group 3 metformin hydrochloride, reason is the same production lines, has been listed in the United States, apply for generics in domestic market. 

 

Learned, February 7, 2017, hengrui pharmaceutical announcement, the company product benzene sulfonic shun atracurium injection for FDA approval, has the qualification of sales of the products in the United States. Shiyao group, the meaning of pharmaceutical metformin hydrochloride (zyban), metformin hydrochloride (tablets), respectively, on April 17, 2008, July 11, 2016 in the United States approved listing. 

 

15th batch of quasi "priority review of applications for drug registration of the public list is as follows: