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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: olutasidenib
Trade Name: Rezlidhia
Date Designated: 04/27/2017
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Approved
Rigel Pharmaceuticals, Inc.
611 Gateway Boulevard
Suite 900
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: olutasidenib
Trade Name: Rezlidhia
Marketing Approval Date: 12/01/2022
Approved Labeled Indication: treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
Exclusivity End Date: 12/01/2029 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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