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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: One, two, three, or four antisense oligonucleotides of Phosphorodiamidate morpholino oligomer combination that skips exons 4, 5, 6, and 7 of the gamma sarcoglycan (SGCG) gene
Date Designated: 07/18/2017
Orphan Designation: Treatment of limb-girdle muscular dystrophy type 2C that have mutations or deletions in exons 4, 5, 6, or 7of gamma sarcoglycan gene
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kurt+Peter Foundation
P. O. Box 691
Menlo Park, California 94025
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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