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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ramucirumab
Trade Name: CYRAMZA
Date Designated: 11/04/2011
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: ramucirumab
Trade Name: CYRAMZA
Marketing Approval Date: 05/10/2019
Approved Labeled Indication: CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been treated with sorafenib.
Exclusivity End Date: 05/10/2026 
Exclusivity Protected Indication* :  CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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