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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-{2-[N-((3S)(3-piperidyl))carbamoyl]-5-[2-(3-fluorophenyl)ethynyl](3-thienyl)}aminoamide
Date Designated: 04/29/2019
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pharos iBio Co., Ltd.
#1408, 38, Heungan-daero 427 beon-gil
Gwanyang-dong, Sungji Starwith),
Dongan-gu, Anyang-si Gyeonggi-do
South Korea

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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