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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: decitabine and tetrahydrouridine
Date Designated: 09/19/2016
Orphan Designation: Treatment of sickle cell disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novo Nordisk Inc.
800 Scudders Mill Rd.
P.O. Box 846
Plainsboro, New Jersey 08536
United States

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.