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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ((2S,5S)-5-(4-amino-5-(4-(2,3-difluorophenoxy)phenyl)imidazo[5,1-f][1,2,4]triazin-7-yl)tetrahydro-2H-pyran-2-yl)methanol
Date Designated: 10/02/2023
Orphan Designation: Treatment of Central Nervous System Lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
No. 199 Liangjing Road, Zhangjiang Hi-Tech Park
Pudong New Area
Shanghai
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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