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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: darvadstrocel
Date Designated: 02/22/2022
Orphan Designation: Treatment of anal fistulas in patients without Crohn's disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/30/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Takeda Development Center Americas, Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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