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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Cabiralizumab
Date Designated: 01/11/2016
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Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/15/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Five Prime Therapeutics, Inc.
111 Oyster Point Boulevard
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.