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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
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.
Pfizer, Inc.
445 Eastern Point Road
Groton, Connecticut 06340
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.
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