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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avapritinib
Trade Name: Ayvakit
Date Designated: 01/06/2016
Orphan Designation: Treatment of gastrointestinal stromal tumors
Orphan Designation Status: Designated/Approved
Blueprint Medicines Corporation
45 Sidney Street
Suite 200
Cambridge, Massachusetts 02139
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: avapritinib
Trade Name: Ayvakit
Marketing Approval Date: 01/09/2020
Approved Labeled Indication: Treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
Exclusivity End Date: 01/09/2027 
Exclusivity Protected Indication* :  Treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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