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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 cedazuridine
Trade Name: Inqovi
Date Designated: 07/10/2024
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Taiho Oncology Inc.
4420 Rosewood Drive, Suite 200
Pleasanton, California 94588
United States

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

Marketing approved:

1 Generic Name: decitabine and cedazuridine
Trade Name: Inqovi
Marketing Approval Date: 05/13/2026
Approved Labeled Indication: in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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