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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: clenbuterol
Date Designated: 10/27/2014
Orphan Designation: Adjunctive therapy with enzyme replacement therapy in the treatment of Pompe disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Duke University Medical Center
Department of Pediatrics
Box 103856
Durham, North Carolina 27710
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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