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U.S. Department of Health and Human Services

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Total number of orphan drug designation decisions that resulted in orphan designation in the month

Dictionary: Review: The review of an application (original or amended) that is completed and the decision rendered during the indicated month. The decision can be (1) the designation is given, (2) the designation is denied, or (3) the designation decision is on hold awaiting further information from the sponsor.

Orphan Designation: The sponsor’s product, which is described in the designation application along with the rare disease or condition the product treats, meets the regulatory criteria for an orphan designation, which allows the sponsor to take advantage of special incentives provided by the 1983 Orphan Drug Act and subsequent amendments.

Information is current as of December 31, 2014.

Fiscal Year - 2013

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Oct 2012N/A13
Nov 2012N/A14
Dec 2012N/A22
Jan 2013N/A23
Feb 2013N/A6
Mar 2013N/A22
Apr 2013N/A19
May 2013N/A23
Jun 2013N/A15
Jul 2013N/A12
Aug 2013N/A22
Sep 2013N/A43

FY 2013 Total: 234


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.