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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-aza-2'-dexocytidine combined with 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-hydroxy-1,3-diazinan-2-one
Date Designated: 02/16/2017
Orphan Designation: Treatment of thalassemia
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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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