Search Orphan Drug Designations and Approvals
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Generic Name: | [4-[(2R)-3-(3,4-dihydro-1H-isoquinolin-2-yl)-2-hydroxy-propyl]-8-[(1-methyl-4-piperidyl)oxy]-2,3-dihydro-1,4-benzoxazepin-5-one] |
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Date Designated: | 11/22/2022 |
Orphan Designation: | Treatment of glioblastoma multiforme |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
SK Life Science Inc. 461 From Road 5th floor Paramus, New Jersey 07652 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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