Search Orphan Drug Designations and Approvals
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Generic Name: | pitolisant |
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Date Designated: | 02/12/2024 |
Orphan Designation: | Treatment of Prader-Willi syndrome (PWS) |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Harmony Biosciences, LLC 630 W Germantown Pike Suite 215 Plymouth Meeting, Pennsylvania 19462 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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