2010 FDA (NME) drug approvals: few were based upon US inventions or sold by US companies
In any given year, the U.S. Food and Drug Administration (FDA) grants marketing approval to new drugs. The most important category* are those classified as “new molecular entities” or NMEs. Chen Xingzhi has collected data on the 2010 NMEs included in the FDA Orange Book here: http://goo.gl/W78Tbk. Some of the data are summarized below:
- Among products listed in the FDA Orange Book in 2010, 15 were classified as NMEs.
- Among all of the NMEs, 43 patents were listed in the FDA Orange Book, covering 12 of the 15 products.