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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: glucarpidase
Trade Name: Voraxaze
Date Designated: 08/19/2003
Orphan Designation: Treatment of patients at risk of methotrexate toxicity
Orphan Designation Status: Designated/Approved
BTG International Inc.
5214 Maryland Way
Suite 405
Brentwood, Tennessee 37027
United States

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

Marketing approved:

1 Generic Name: glucarpidase
Trade Name: Voraxaze
Marketing Approval Date: 01/17/2012
Approved Labeled Indication: Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.
Exclusivity End Date: 01/17/2019 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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