Search Orphan Drug Designations and Approvals
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Generic Name: | pyridoxal-5¿ phosphate monohydrate (P5P) |
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Date Designated: | 01/04/2017 |
Orphan Designation: | Treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Medicure International Inc. 2-1250 Waverley Street Winnipeg Canada 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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