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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Creatine
Date Designated: 10/11/2005
Orphan Designation: Treatment of Huntington's disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/13/2017
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marathon Pharmaceuticals, LLC
1033 Skokie Blvd
Suite 600
Northbrook, Illinois 60062
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.