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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sodium phenylbutyrate
Trade Name: Pheburane
Date Designated: 06/06/2013
Orphan Designation: Treatment of urea cycle disorders
Orphan Designation Status: Designated/Approved
Medunik Canada Inc
950 Boulevard Michèle-Bohec

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: sodium phenylbutyrate
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  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.