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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide
Date Designated: 02/08/2021
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/25/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Alexion Pharmaceuticals Inc.
121 Seaport Blvd
Boston, Massachusetts 02210
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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