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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-fluoro-4-(7''-fluoro-2''-methylspiro[cyclopentane-1,3''-indol]-5''-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine fumarate
Date Designated: 09/08/2020
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Gan & Lee Pharmaceuticals USA Corporation
520 US Highway 22 East
Suite 302
Bridgewater, New Jersey 08807
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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