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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: exendin-(9-39)
Date Designated: 06/01/2011
Orphan Designation: Treatment of congential hyperinsulinenic hypoglycemia and other causes of hyperinsulinemic hypoglycemia in adults and children
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/14/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
The Children's Hospital of Philadelphia
Children's Hospital of Phil. Research Institute
Abramson Research Center
Philadelphia, Pennsylvania 19104
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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