Search Orphan Drug Designations and Approvals
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Generic Name: | ivosidenib | ||||||||||||||||
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Trade Name: | Tibsovo | ||||||||||||||||
Date Designated: | 04/26/2017 | ||||||||||||||||
Orphan Designation: | Treatment of cholangiocarcinoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | ivosidenib |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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