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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant human galactocerebrosidase (rhGALC);
Date Designated: 12/12/2011
Orphan Designation: Treatment of globoid cell leukodystrophy (Krabbe Disease)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Chiesi USA, Inc.
175 Regency Woods Place
Ste. 600
Cary, North Carolina 27518
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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