PharmExec Blog

FDA Approvals Down on Last Two Years

Approved2A new FDA report summarizes the new drug approvals for 2010, and highlights some surprising numbers compared to years past.

According to a recent FDA report, FDA’s Center for Drug Evaluation and Research (CDER) approved 21 New Molecular Entities (NMEs) in 2010, which is less than in 2009 (26) and 2008 (24), but greater than the two years previous to that.

Looking back even further at a ten-year average, since 2001, CDER has averaged slightly fewer than 23 NME approvals per year (22.9), closer to the 21 approved in 2010. Of the past decade, 2004 clocked in as the year with the highest number of NMEs approved (36), ten more than the next highest approval year, 2009 (26). The lowest approval number of the decade came in 2002 (17). It’s also important to note when lookin back over data of the past decade that 2004-2010 represents applications for NMEs filed under New Drug Applications (NDAs) and therapeutic biologics filed under Original Biologic License Applications (BLAs), but that 2001-2003 does not include therapeutic biologics.

The report also notes that “if the number of applications does not increase, CDER does not expect to see much of a year-to-year increase in approvals.

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One Comment

  1. Angelo Panzica
    Posted February 25, 2011 at 2:39 pm | Permalink

    Hi Jennifer
    I am trying to find information on how many NDA submissions went in to FDA over the last few years. You talk about no increase in approvals but just wondering if that coincides with decrease submissions or more failed submissions. Do you have this information?


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