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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ivosidenib
Date Designated: 05/20/2020
Orphan Designation: Treatment of myelodysplastic syndromes
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Servier Pharmaceuticals LLC
200 Pier Four Blvd
Boston, Massachusetts 02210
United States

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

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