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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Pegaspargase
Trade Name:  Oncaspar; Asparlas
Date Designated:  10/20/1989
Orphan Designation:  Treatment of acute lymphocytic leukemia.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/01/1994 
Approved Labeled Indication:  Combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of L-asparaginase.
Exclusivity End Date:    02/01/2001 
Exclusivity Protected Indication* :  
Servier Pharmaceuticals LLC
200 Pier Four Blvd
Boston, Massachusetts 02210
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  Pegaspargase
Trade Name:  Oncaspar; Asparlas
Date Designated:  10/20/1989
Orphan Designation:  Treatment of acute lymphocytic leukemia.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/20/2018 
Approved Labeled Indication:  ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
Exclusivity End Date:     
Exclusivity Protected Indication* :  
Servier Pharmaceuticals LLC
200 Pier Four Blvd
Boston, Massachusetts 02210
United States

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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