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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pyridoxal-5¿ phosphate monohydrate (P5P)
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
Medicure International Inc.
2-1250 Waverley Street
Winnipeg
Canada

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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