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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: olezarsen
Trade Name: Tryngolza
Date Designated: 02/14/2024
Orphan Designation: Treatment of Familial Chylomicronemia Syndrome
Orphan Designation Status: Designated/Approved
Ionis Pharmaceuticals
2855 Gazelle Court
Carlsbad, California 92010
United States

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

Marketing approved:

1 Generic Name: olezarsen
Trade Name: Tryngolza
Marketing Approval Date: 12/19/2024
Approved Labeled Indication: adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)
Exclusivity End Date: 12/19/2031 
Exclusivity Protected Indication* :  adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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