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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-(3-(2-amino-4-oxo-4,7-dihydro-3 H-pyrrolo[2,3- d]pyrimidin-6-yl)propyl)thiophene-2-carbonyl)- L-glutamic acid)
Date Designated: 03/30/2021
Orphan Designation: Treatment of Mesothelioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
FLAG Therapeutics, Inc.
9168 Wooden Road
Raleigh, North Carolina 27617-8203
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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