RPT-Fitch: Slowdown in FDA approvals within expectations for global pharmaceuticals
Sept 23 (Reuters) - (The following statement was released by the rating agency)
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 Fitch Ratings' expectations, according to a report published today.
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. Fitch notes, however, it is still too early to determine the benefit to developers of the newfound status.
The full 'Global Pharmaceutical R&D Pipeline' is available at 'www.fitchratings.com.' The report provides detailed analysis on the R&D pipelines and upcoming patent expirations for all the companies in Fitch's pharmaceutical ratings portfolio.
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