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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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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