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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-[(1,3-Benzoxazol-2-yl)amino]-N-[2-(2-hydroxyethoxy)ethyl]-1-methyl-1H-benzimidazole-5- carboxamide monophosphate
Date Designated: 09/01/2022
Orphan Designation: Treatment of Sickle Cell Disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/11/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Astellas Pharma Global Development, Inc.
1 Astellas Way
Northbrook, Illinois 60062
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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