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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: asparaginase erwinia chrysanthemi (recombinant)-rywn
Trade Name: Rylaze
Date Designated: 06/22/2021
Orphan Designation: Treatment of Acute lymphoblastic leukemia
Orphan Designation Status: Designated/Approved
Jazz Pharmaceuticals Ireland Limited
Waterloo Exchange, Waterloo Road
Fifth floor
Dublin D04 E5W7
Ireland

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

Marketing approved:

1 Generic Name: asparaginase erwinia chrysanthemi (recombinant)-rywn
Trade Name: Rylaze
Marketing Approval Date: 06/30/2021
Approved Labeled Indication: As a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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