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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 7-fluoro-1-isopropyl-3-methyl-8-{6-[3-(1-piperidinyl)propoxy]-3- pyridinyl}-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one
Date Designated: 02/02/2026
Orphan Designation: treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington, Delaware 19803
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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