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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sorafenib
Date Designated: 02/28/2019
Orphan Designation: Treatment of desmoid tumors/aggressive fibromatosis
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/22/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare Pharmaceuticals, Inc.
100 Bayer Boulevard
P.O. Box 915
Whippany, New Jersey 07981
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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