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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: D-mannose
Date Designated: 10/22/2026
Orphan Designation: treatment of mannose phosphate isomerase - congenital disorder of glycosylation (MPI-CDG)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kalevala Therapeutics, Inc.
1111B S Governors Ave
STE 28277
Dover, Delaware 19904
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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