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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nirogacestat
Trade Name: Ogsiveo
Date Designated: 06/07/2018
Orphan Designation: Treatment of desmoid tumor (aggressive fibromatosis)
Orphan Designation Status: Designated/Approved
SpringWorks Therapeutics, Inc.
100 Washington Boulevard
Stamford, Connecticut 06902
United States

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

Marketing approved:

1 Generic Name: nirogacestat
Trade Name: Ogsiveo
Marketing Approval Date: 11/27/2023
Approved Labeled Indication: for adult patients with progressing desmoid tumors who require systemic treatment
Exclusivity End Date: 11/27/2030 
Exclusivity Protected Indication* :  for adult patients with progressing desmoid tumors who require systemic treatment
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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