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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: 08/19/2014
Orphan Designation: Treatment of maple syrup urine disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Acer Therapeutics, Inc.
One Gateway Center
300 Washington Street, Suite 351
Newton, Massachusetts 02458
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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