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  • harriganrobert Dec 12, 2011 6:07 PM Flag

    New Drugs

    How Many New Drugs Did FDA Approve Last Year?
    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).

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