• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: ivosidenib
Trade Name: Tibsovo
Date Designated: 04/26/2017
Orphan Designation: Treatment of cholangiocarcinoma
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: ivosidenib
Trade Name: Tibsovo
Marketing Approval Date: 08/25/2021
Approved Labeled Indication: Treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
Exclusivity End Date: 08/25/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-