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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (R)-1-(3,3-difluoro-1-methlypiperidin-4-yl)-8-(6-methoxypyridin-3-yl)-3-methyl-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one
Date Designated: 02/07/2023
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Wayshine Biopharm, INC
957 Ferndale Dr,
Corona, California 92881
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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