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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: A potent and selective inhibitor of Gamma Secretase-mediated NOTCH signaling
Date Designated: 05/08/2019
Orphan Designation: Treatment of Adenoid cystic carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Immunome
18702 North Creek Parkway, Suite 100
Bothell, Washington 98011
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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