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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: Buphenyl
Date Designated: 11/22/1993
Orphan Designation: Treatment of urea cycle disorders: carbamylphosphate synthetase deficiency, ornithine transcarbamylase deficiency, and arginiosuccinic acid synthetase deficiency.
Orphan Designation Status: Designated/Approved
Medicis Pharmaceutical Corp.
8125 N. Hayden Road
Scottsdale, Alaska 85258
United States

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

Marketing approved:

1 Generic Name: sodium phenylbutyrate
Trade Name: Buphenyl
Marketing Approval Date: 04/30/1996
Approved Labeled Indication: Adjunctive therapy in the chronic managment of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
Exclusivity End Date: 04/30/2003 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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