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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Small molecular inhibitor of fibroblast growth factor receptor (FGFR)-1,2 and 3 tyrosine kinases
Date Designated: 03/01/2022
Orphan Designation: Treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Abbisko Therapeutics Co.,Ltd
Building 3, Lane 898, Halei Road, Zhangjiang High-Tech Park
Shanghai, Shanghai 201210
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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