Search Orphan Drug Designations and Approvals
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Generic Name: | recombinant humanized monoclonal antibody of the immunoglobulin G1 subclass directed against colony stimulating factor-1 receptor expressed on macrophages |
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Date Designated: | 05/14/2014 |
Orphan Designation: | Treatment of pigmented villonodular synovitis and tenosynovial giant cell tumor |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 04/21/2017 |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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