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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: 08/01/1991
Orphan Designation: For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma.
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: 03/07/2008
Approved Labeled Indication: Levoleucovorin rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists
Exclusivity End Date: 03/07/2015 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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