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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: idasanutlin
Date Designated: 11/29/2017
Orphan Designation: Treatment of polycythemia vera
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/07/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hoffmann-La Roche Inc.
430 East 29th Street
New York, New York 10016
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.