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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 3-(5-cyano-4-(cyclopropylamino)pyridin-2-yl)-1-(6-formyl-5-((4-methyl-2-oxopiperazin-1-yl)methyl)pyridin-2-yl)-1-methylurea
Date Designated: 03/27/2023
Orphan Designation: Treatment of soft tissue sarcoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Wuxi Abbisko Biomedical Technology Co., Ltd.
Building E, Xingye Building, 97-1
Linghu Avenue
Wuxi, Jiangsu 214000
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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