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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: levoleucovorin
Trade Name: Fusilev
Date Designated: 12/18/1990
Orphan Designation: For use in combination chemotherapy with the approved agent 5-fluorouracil in the palliative treatment of metastatic adenocarcinoma of the colon and rectum
Orphan Designation Status: Designated/Approved
Acrotech Biopharma LLC
279 Princeton Hightstown Road
East Windsor, New Jersey 08520
United States

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

Marketing approved:

1 Generic Name: levoleucovorin
Trade Name: Fusilev
Marketing Approval Date: 04/29/2011
Approved Labeled Indication: For use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer
Exclusivity End Date: 04/29/2018 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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