Analysis: U.S. Orphan-drug Approvals Hit Record High in 2014

Sunday, March 1, 2015

Source: Smart Brief

An analysis of data from the FDA's Orphan Drug Designations and Approvals database showed that the agency approved 49 orphan drugs last year, a 53% increase compared with 2013. The number of orphan-drug designations granted by the FDA's Office of Orphan Products Development also increased nearly 13% to 293, while the number of orphan-status requests reached 467, up almost 35% over 2013. All three numbers were record highs. According to the analysis, the Office of Orphan Products Development is on track to eclipse the record for orphan drug-designation requests, which was set in 2014.

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