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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
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:     
Exclusivity Protected Indication* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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