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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Spiro[3H-Indole-3,2¿-pyrrolidin]-2(1H)-one derivative
Date Designated: 06/24/2022
Orphan Designation: Treatment of soft tissue sarcoma (STS)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/04/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
PO Box 368
Ridgefield, Connecticut 06877
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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