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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
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.

Marketing approved:

1 Generic Name: Pegaspargase
Trade Name: Oncaspar; Asparlas
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* :  
2 Generic Name: Pegaspargase
Trade Name: Oncaspar; Asparlas
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: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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