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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: 06/04/2015
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated/Approved
Bayer HealthCare Pharmaceuticals, Inc.
100 Bayer Blvd
P. O. Box 915
Whippany, New Jersey 07981
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: 04/27/2017
Approved Labeled Indication: Treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with sorafenib.
Exclusivity End Date: 04/27/2024 
Exclusivity Protected Indication* :   Treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with sorafenib.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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