Number of FDA approved orphan designations in the United States from 2000 to 2014

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Number of orphan designations
200013
20016
200214
200312
200413
200517
200624
200716
200815
200920
201014
201125
201225
201331
201440

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This statistic displays the number of FDA approved orphan designations per year in the United States from 2000 to 2014. In 2000, there were 13 FDA approved orphan designations in the country. Orphan drugs are used to target rare diseases or disorders, which in the United States is defined as less than 200,000 patients. The development of orphan drugs are currently incentivized in the United States through the Orphan Drug Act of 1983.
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Release date
October 2015
Region
United States
Survey time period
2000 to 2014

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