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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vorasidenib
Trade Name: Voranigo
Date Designated: 09/10/2018
Orphan Designation: Treatment of glioma
Orphan Designation Status: Designated/Approved
Servier Pharmaceuticals LLC
200 Pier Four Blvd
Boston, Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: vorasidenib
Trade Name: Voranigo
Marketing Approval Date: 08/06/2024
Approved Labeled Indication: treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection
Exclusivity End Date: 08/06/2031 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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