As the chart indicates, last year, there were 18 NMEs approved and three biologics, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year, although there is a caveat: biologics were not included during 2001 through 2003.
However, new applications are declining. Last year, the FDA received 23, a notable drop from the 37 applications received in 2009, 34 in 2008 and 35 in 2007. There were 26 applications received in 2006. Significantly, except for 2002, the 23 NME applications that were filed with CDER last year was the lowest number filed in more than 15 years (here is the FDA report, by the way).
Just imagine that, back in 1998, there were 43 NME applications filed and 41 in 1997 - and 45 back in 1996 (but again, between 2001 and 2003, NMEs did not include therapeutic biologics). Not surprisingly, the FDA anticipates that, "if the number of applications does not increase, CDER does not expect to see much of a year-to-year increase in approvals." And so, drugmakers and biotechs may complain the FDA is not moving quickly enough, but then, neither are they.