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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Ripretinib
Trade Name:  
Date Designated:  10/02/2014
Orphan Designation:  Treatment of gastrointestinal stromal tumors (GIST)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/15/2020 
Approved Labeled Indication:  QINLOCK (ripretinib) is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Exclusivity End Date:    05/15/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Deciphera Pharmaceuticals, LLC
200 Smith Street
Waltham, Massachusetts 02451
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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