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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lenvatinib
Trade Name: LENVIMA
Date Designated: 03/27/2014
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated/Approved
Eisai Inc.
200 Metro Blvd.
Nutley, New Jersey 07110-6102
United States

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

Marketing approved:

1 Generic Name: lenvatinib
Trade Name: LENVIMA
Marketing Approval Date: 08/15/2018
Approved Labeled Indication: LENVIMA is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Exclusivity End Date: 08/15/2025 
Exclusivity Protected Indication* :   LENVIMA is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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