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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
Date Designated: 07/02/1992
Orphan Designation: Treatment for sickling disorders, which include S-S hemoglobinopathy, S-C hemoglobinopathy, and S-thalassemia hemoglobinopathy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.