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U.S. Department of Health and Human Services

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Total number of orphan drug approvals in the month requiring exclusivity determinations

Dictionary: These are orphan products receiving marketing approval, which will require OOPD review to determine orphan drug exclusivity status.

Information is current as of September 30, 2020.

Fiscal Year - 2015

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Oct 2014N/A4
Nov 2014N/A5
Dec 2014N/A8
Jan 2015N/A4
Feb 2015N/A3
Mar 2015N/A4
Apr 2015N/A0
May 2015N/A2
Jun 2015N/A0
Jul 2015N/A3
Aug 2015N/A2
Sep 2015N/A3

FY 2015 Total: 38

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.