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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt
Date Designated:  09/28/2017
Orphan Designation:  Treatment of Acute Myeloid Leukemia
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Trovagene, Inc.
11055 Flintkote Avenue
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 Jan. 1, 2013, to the present.
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