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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.
1180 Veterans Blvd.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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