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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Fedratinib
Trade Name: INREBIC
Date Designated: 05/18/2009
Orphan Designation: Treatment of secondary and primary myelofibrosis
Orphan Designation Status: Designated/Approved
Impact Biomedicines, Inc. a wholly-owned subsidiary of Celgene Corporation
86 Morris Avenue
Summit, New Jersey 07901
United States

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

Marketing approved:

1 Generic Name: Fedratinib
Trade Name: INREBIC
Marketing Approval Date: 08/16/2019
Approved Labeled Indication: INREBIC® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
Exclusivity End Date: 08/16/2026 
Exclusivity Protected Indication* :  For the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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