Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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: enasidenib
Trade Name: Idhifa
Date Designated: 06/12/2014
Orphan Designation: Treatment of acute myelogenous leukemia
Orphan Designation Status: Designated/Approved
Celgene Corporation
9225 Indian Creek Parkway
Suite 900
Overland Park, Kansas 66210
United States

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

Marketing approved:

1 Generic Name: enasidenib
Trade Name: Idhifa
Marketing Approval Date: 08/01/2017
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test
Exclusivity End Date: 08/01/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-