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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  glibentek (glibenclamide oral suspension)
Date Designated:  06/08/2016
Orphan Designation:  Treatment of neonatal diabetes (monogenic forms of diabetes that present in infancy)
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
15 Rue Béranger
Paris, Île-de-France

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.