US FDA approves 24 NMEs/novel biologicals in 2008
This article was originally published in Scrip
Executive Summary
The USFDA's drugs centre (CDER) approved 21 new molecular entities and three novel biologicals in 2008, a 33% increase over its prior-year total of 18 and the highest level of novel medicine approvals since 2004. The centre also surpassed its 2007 totals for all original NDA and BLA approvals, with approximately 93 in 2008, up from 78 in the prior year.