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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: regorafenib
Trade Name: Stivarga
Date Designated: 01/12/2011
Orphan Designation: Treatment gastrointestinal stromal tumors
Orphan Designation Status: Designated/Approved
Bayer HealthCare Pharmaceuticals, Inc.
P. O. Box 1000
Montvale, New Jersey 07045
United States

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

Marketing approved:

1 Generic Name: regorafenib
Trade Name: Stivarga
Marketing Approval Date: 02/25/2013
Approved Labeled Indication: Treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
Exclusivity End Date: 02/25/2020 
Exclusivity Protected Indication* :  Treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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