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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Azacitidine
Trade Name: ONUREG
Date Designated: 06/18/2008
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb
86 Morris Ave
Summit, New Jersey 07901
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Azacitidine
Trade Name: ONUREG
Marketing Approval Date: 09/01/2020
Approved Labeled Indication: ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy
Exclusivity End Date: 09/01/2027 
Exclusivity Protected Indication* :  ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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