Slowdown in FDA Approvals within Expectations

Mon, 09/23/2013 - 1:38pm
The U.S. Food and Drug Administration (FDA) approved fewer new molecular entities (NME) through August 2013 than in the same period in 2012, although this moderation is in-line with  expectations, according to a report published today by Fitch Ratings Inc.
In the first eight months of 2013, the FDA cleared 18 novel medications for U.S. marketing compared to 22 during the same year-to-date period in 2012. Fitch notes that in 2012, the FDA authorized 39 new pharmaceuticals, the highest number since 2004.
The FDA continues to utilize a new means for accelerating approval of investigational pharmaceuticals that treat serious or life threatening conditions - breakthrough therapy status. The new designation arising from the enactment of the FDA Safety and Innovation Act of 2012 was granted to 26 drug candidates (out of 83 applications) from October 2012 to early September 2013. The designation indicates the agency's willingness to expedite important medicines. It is, however, still too early to determine the benefit to developers of the newfound status, according to the ratings company.
Date: September 23, 2013

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