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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: 12/27/2012
Orphan Designation: Treatment of follicullar, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer
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: 02/13/2015
Approved Labeled Indication: Treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer
Exclusivity End Date: 02/13/2022 
Exclusivity Protected Indication* :  Treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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