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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-(2-Methoxyethyl)-6-methyl-N-[(3-methyl-2-thienyl)methyl]-2-oxo-1,2-dihydropyridine-4-carboxamide
Date Designated: 08/09/2023
Orphan Designation: Treatment of Glycogen Storage Disease type IV (GSD-IV)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Golden Heart Flower, Ltd.
2 Hamal Street
Industrial Park North
Afula 1857107
Israel

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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