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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Erwinia L-asparaginase
Date Designated: 01/25/1985
Orphan Designation: For use as an alternative to E. coli asparaginase in those situations where repeat courses of asparaginase therapy for acute lymphoblastic leukemia are required or where allergic reactions force the discontinuance of the E. coli preparation.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lyphomed, Inc.

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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