Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Benzoate and phenylacetate
Trade Name: Ucephan
Date Designated: 01/21/1986
Orphan Designation: For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency.
Orphan Designation Status: Designated/Approved
ImmunexImmunex
2525 McGaw Avenue
P.O. Box 19791
Irvine, California 92623
United States

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

Marketing approved:

1 Generic Name: Benzoate and phenylacetate
Trade Name: Ucephan
Marketing Approval Date: 12/23/1987
Approved Labeled Indication:
Exclusivity End Date: 12/23/1994 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-