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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, 2019.

Fiscal Year - All

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TimeTargetNumber
Oct 2012N/ATBD
Nov 2012N/ATBD
Dec 2012N/ATBD
Jan 2013N/A1
Feb 2013N/A3
Mar 2013N/A2
Apr 2013N/A3
May 2013N/A5
Jun 2013N/A3
Jul 2013N/A1
Aug 2013N/A2
Sep 2013N/A1
Oct 2013N/A3
Nov 2013N/A3
Dec 2013N/A3
Jan 2014N/A3
Feb 2014N/A4
Mar 2014N/A3
Apr 2014N/A6
May 2014N/A0
Jun 2014N/A1
Jul 2014N/A8
Aug 2014N/A4
Sep 2014N/A4
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
Oct 2015N/A6
Nov 2015N/A5
Dec 2015N/A8
Jan 2016N/A3
Feb 2016N/A2
Mar 2016N/A5
Apr 2016N/A5
May 2016N/A5
Jun 2016N/A2
Jul 2016N/A0
Aug 2016N/A0
Sep 2016N/A0
Oct 2016N/A0
Nov 2016N/A0
Dec 2016N/A0
Jan 2017N/A0
Feb 2017N/A0
Mar 2017N/A0
Apr 2017N/A12
May 2017N/A6
Jun 2017N/A9
Jul 2017N/A2
Aug 2017N/A9
Sep 2017N/A6
Oct 2017N/A6
Nov 2017N/A9
Dec 2017N/A8
Jan 2018N/A2
Feb 2018N/A1
Mar 2018N/A6
Apr 2018N/A9
May 2018N/A8
Jun 2018N/A14
Jul 2018N/A7
Aug 2018N/A10
Sep 2018N/A9
Oct 2018N/A4
Nov 2018N/A11
Dec 2018N/A9
Jan 2019N/A1
Feb 2019N/A4
Mar 2019N/A2
Apr 2019N/A3
May 2019N/A13
Jun 2019N/A12
Jul 2019N/A3
Aug 2019N/A13
Sep 2019N/A6

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.

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