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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: eribulin mesylate
Trade Name: Halaven
Date Designated: 05/14/2012
Orphan Designation: Treatment of soft tissue sarcoma
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: eribulin mesylate
Trade Name: Halaven
Marketing Approval Date: 01/28/2016
Approved Labeled Indication: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen
Exclusivity End Date: 01/28/2023 
Exclusivity Protected Indication* :  Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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