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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ruxolitinib
Trade Name: Jakafi
Date Designated: 03/26/2010
Orphan Designation: Treatment of polycythemia vera
Orphan Designation Status: Designated/Approved
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

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

Marketing approved:

1 Generic Name: ruxolitinib
Trade Name: Jakafi
Marketing Approval Date: 12/04/2014
Approved Labeled Indication: Treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
Exclusivity End Date: 12/04/2021 
Exclusivity Protected Indication* :  Treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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