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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-(4-(1-cyclopropyl-4-fluoro-2-methyl-1H-benzo[d]imidazol-6-yl)-5-fluoropyrimidin-2-yl)-6-(2-(dimethylamino)ethyl-5,6,7,8-tetrahydro-1,6-naphthyridin-2-amine maleate
Date Designated: 03/21/2023
Orphan Designation: Treatment of Liposarcoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Pharma Biotherapeutics USA Inc.
3545 John Hopkins Ct., Ste 160
San Diego, California 92121
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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