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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fostamatinib disodium hexahydrate
Trade Name:
Date Designated: 08/25/2015
Orphan Designation: Treatment of immune thrombocytopenic purpura
Orphan Designation Status: Designated/Approved
Rigel Pharmaceuticals, Inc.
1180 Veterans Boulevard
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: fostamatinib disodium hexahydrate
Trade Name:
Marketing Approval Date: 04/17/2018
Approved Labeled Indication: TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Exclusivity End Date: 04/17/2025 
Exclusivity Protected Indication* :  TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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