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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
Trade Name: Erwinase
Date Designated: 07/30/1986
Orphan Designation: Treatment of acute lymphocytic leukemia.
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/10/2021
Jazz Pharmaceuticals, Inc.
3180 Porter Drive
Palo Alto, California 94304
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: Erwinia L-asparaginase
Trade Name: Erwinase
Marketing Approval Date: 11/18/2011
Approved Labeled Indication: Treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
Exclusivity End Date: 11/18/2018 
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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