FDA approved orphan drugs 1983-2018, by approval sequence

This statistic depicts the number of FDA-approved orphan drugs between 1983 and 2018, sorted by approval sequence. According to the FDA data, of the 35 approved orphan drugs in 2017, 30 were for orphan indications only, while three drugs were simultaneously orphan and non-orphan.

Number of FDA-approved orphan drugs between 1983 and 2018, by approval sequence

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Release date

October 2018


United States

Survey time period

as of September 2018

Supplementary notes

Total number of drugs 1983−2018 YTD=503; Counts distinct drugs approved with any orphan indication since the passage of the Orphan Drug Act. Includes drug approvals through Aug 2018.

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Statistics on "Orphan drugs"

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