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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: belumosudil
Trade Name: Rezurock
Date Designated: 10/05/2017
Orphan Designation: Treatment of graft versus host disease (GVHD)
Orphan Designation Status: Designated/Approved
Kadmon Pharmaceuticals, LLC
55 Cambridge Parkway, Suite 300E
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: belumosudil
Trade Name: Rezurock
Marketing Approval Date: 07/16/2021
Approved Labeled Indication: Treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy
Exclusivity End Date: 07/16/2028 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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