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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-(3-(2-(2,3-difluoro-4-(4-(2-hydroxyethyl)piperazin-1-yl)phenylamino)quinazolin-8-yl)phenyl)acrylamide
Date Designated: 09/05/2017
Orphan Designation: Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Checkpoint Therapeutics, Inc.
2 Gansevoort Street
9th Floor
New York, New York 10014
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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