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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-Acetylmannosamine (ManNAc)
Date Designated: 04/05/2010
Orphan Designation: Treatment of GNE Myopathy (Hereditary Inclusion Body Myopathy Type 2)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Leadiant Biosciences, Inc.
9841 Washingtonian Blvd, Suite 500
Gaithersburg, Maryland 20878
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.