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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bitopertin
Date Designated: 08/16/2017
Orphan Designation: Treatment of ß-thalassemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/09/2018
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hoffmann-La Roche Inc.
c/o Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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