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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: revumenib
Trade Name: Revuforj
Date Designated: 07/11/2024
Orphan Designation: Treatment of acute lymphocytic leukemia
Orphan Designation Status: Designated/Approved
Syndax Pharmaceuticals, Inc.
730 3rd Avenue, Floor 9
New York, New York 10017
United States

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

Marketing approved:

1 Generic Name: revumenib
Trade Name: Revuforj
Marketing Approval Date: 11/15/2024
Approved Labeled Indication: treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older
Exclusivity End Date: 11/15/2031 
Exclusivity Protected Indication* :  treatment of relapsed or refractory acute lymphocytic leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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