An overview of FDA-approved new molecular entities: 1827-2013

Drug Discov Today. 2014 Aug;19(8):1033-9. doi: 10.1016/j.drudis.2014.03.018. Epub 2014 Mar 26.


The pharmaceutical industry is undergoing fundamental change and its future is unclear. We performed a meta-analysis by cataloging FDA-approved legacy drugs and new molecular entities (NMEs). Objective information regarding scientific, medical and commercial activities was captured and provides insight into processes governing drug development. In this report, we review the rates of NME introduction through to the end of 2013. Recent trends show the emergence of a handful of companies that controls two-thirds of NMEs. We also report growth in the number of NMEs controlled by marketing organizations that have little or no internal drug discovery or development activities. This trend has increased dramatically since 2000 and could raise important questions about the future landscape and viability of drug discovery and development.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Drug Approval*
  • Drug Discovery*
  • Drug Industry
  • Time Factors
  • United States
  • United States Food and Drug Administration