How Many New Drugs Did FDA Approve Last Year? 20 Comments By Ed Silverman // February 18th, 2011 // 9:35 am
The rate at which the FDA approved new molecular entities - including NME’s filed under New Drug Applications (NDAs) and therapeutic biologics filed under Original Biologic License Applications (BLAs) - declined last year from the previous two years, according to new data released by the FDA.
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).
Well then 2010 was a great year then. It appears that more bio-tech companies are being careful to only submit good candidates. 23 new drug applications submitted in 2010 and 21 approved. That's over a 91 percent approval rate. It doesn't get too much better then that.
Exactly, with the economy the way it is, pharma is taking less chances. If Pfizer didn't think Lpath was one of the winners they would not have made a deal with them, and if I didn't think they were going to get approved I wouldn't invest in them. DYODD
Your using an article written in February 2011 as your basis for current FDA trend? Check this link to FDA approvals for this year. I believe current year has far surpassed previous in approvals. The link will take you to FDA site where you can filter down to the information needed. Great reference tool for any biotech investor.
Spotlight on Drug Innovation”: An ongoing update of FDA’s Center for Drug Evaluation and Research's novel drug approvals of calendar year 2011 The availability of new drugs often means new treatment options for patients, and advances in health care for the American public. For this reason, "innovation" is a key word throughout the pharmaceutical industry and the healthcare community. FDA's Center for Drug Evaluation and Research (CDER) regulates over-the-counter and brand name and generic prescription drugs. In this function, CDER supports innovation and plays a key role in helping to advance new drug development