Search Orphan Drug Designations and Approvals
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Generic Name: | enasidenib | ||||||||||||||||
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Trade Name: | Idhifa | ||||||||||||||||
Date Designated: | 06/12/2014 | ||||||||||||||||
Orphan Designation: | Treatment of acute myelogenous leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | enasidenib |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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