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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Glasdegib
Trade Name: DAURISMO
Date Designated: 06/28/2017
Orphan Designation: Treatment of acute myeloid leukemia (AML)
Orphan Designation Status: Designated/Approved
Pfizer, Inc.
445 Eastern Point Road
Groton, Connecticut 06340
United States

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

Marketing approved:

1 Generic Name: Glasdegib
Trade Name: DAURISMO
Marketing Approval Date: 11/21/2018
Approved Labeled Indication: DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are >75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Exclusivity End Date: 11/21/2025 
Exclusivity Protected Indication* :  DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are >75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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