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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione
Date Designated:  04/16/2018
Orphan Designation:  Treatment of inherited mitochondrial respiratory chain disease
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
NeuroVive Pharmaceutical AB
Medicon Village

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.