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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mercaptopurine oral solution
Trade Name: Purixan
Date Designated: 08/20/2012
Orphan Designation: Treatment of acute lymphoblastic leukemia in pediatric patients
Orphan Designation Status: Designated/Approved
Nova Laboratories Limited
Martin House
Leicester , Wigston
United Kingdom

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

Marketing approved:

1 Generic Name: mercaptopurine oral solution
Trade Name: Purixan
Marketing Approval Date: 04/28/2014
Approved Labeled Indication: Treatment of patients with acute lymphoblastic leukemia as part of a combination regimen.
Exclusivity End Date: 04/28/2021 
Exclusivity Protected Indication* :  Treatment of patients with acute lymphoblastic leukemia as part of a combination regimen (in pediatric patients).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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