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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pacritinib
Trade Name: Vonjo
Date Designated: 03/13/2008
Orphan Designation: Treatment of primary myelofibrosis (MF), post-polycythemia vera MF, and post-essential thrombocythemia MF
Orphan Designation Status: Designated/Approved
CTI BioPharma Corporation
3101 Western Avenue
Suite 800
Seattle, Washington 98121
United States

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

Marketing approved:

1 Generic Name: pacritinib
Trade Name: Vonjo
Marketing Approval Date: 02/28/2022
Approved Labeled Indication: Treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 x 109/L
Exclusivity End Date: 02/28/2029 
Exclusivity Protected Indication* :  Treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 x 109/L
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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