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Voraxaze Approval History

  • FDA approved: Yes (First approved January 17th, 2012)
  • Brand name: Voraxaze
  • Generic name: glucarpidase
  • Dosage form: Injection
  • Company: BTG International Inc.
  • Treatment for: Methotrexate Overdosage

Voraxaze (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.

Development History and FDA Approval Process for Voraxaze

DateArticle
Jan 17, 2012Approval FDA Approves Voraxaze to Treat Patients with Toxic Methotrexate Levels
Nov 20, 2008Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA

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