FDA Clears 31 New Molecular Entities In 2004, Up 10 From Previous Year
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
NME rebound in 2004? Final count is 31 versus 21 in 2003 – however, 2004 tally includes several atypical new molecular entities. Top 10 pharma companies hold small share of the total, with no companies clearing more than two NMEs during the year. Over 20% of the approvals came in the last two weeks of December