Search Orphan Drug Designations and Approvals
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Generic Name: | sodium phenylbutyrate | |||||||||||||
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Trade Name: | Pheburane | |||||||||||||
Date Designated: | 06/06/2013 | |||||||||||||
Orphan Designation: | Treatment of urea cycle disorders | |||||||||||||
Orphan Designation Status: | Designated/Approved | |||||||||||||
Sponsor: |
Medunik Canada Inc 950 Boulevard Michèle-Bohec Blainville Canada The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | sodium phenylbutyrate |
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Trade Name: | Pheburane | |
Marketing Approval Date: | 06/17/2022 | |
Approved Labeled Indication: | As adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS) | |
Exclusivity End Date: | N/A | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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