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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: avatrombopag maleate
Trade Name:
Date Designated: 09/01/2011
Orphan Designation: Treatment of idiopathic thrombocytopenic purpura
Orphan Designation Status: Designated/Approved
Sobi, Inc.
240 Leigh Farm Road
Suite 245
Durham, North Carolina 27707
United States

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

Marketing approved:

1 Generic Name: avatrombopag maleate
Trade Name:
Marketing Approval Date: 06/26/2019
Approved Labeled Indication: DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
Exclusivity End Date: 06/26/2026 
Exclusivity Protected Indication* :  For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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