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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: momelotinib
Trade Name: Ojjaara
Date Designated: 08/05/2010
Orphan Designation: Treatment of myelofibrosis
Orphan Designation Status: Designated/Approved
GlaxoSmithKline
23 rue François Jacob
Rueil-Malmaison 92500
France

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

Marketing approved:

1 Generic Name: momelotinib
Trade Name: Ojjaara
Marketing Approval Date: 09/15/2023
Approved Labeled Indication: treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia
Exclusivity End Date: 09/15/2030 
Exclusivity Protected Indication* :  treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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