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Erwinaze Approval History

  • FDA approved: Yes (First approved November 18th, 2011)
  • Brand name: Erwinaze
  • Generic name: asparaginase Erwinia chrysanthemi
  • Dosage form: Injection
  • Company: EUSA Pharma, Inc.
  • Treatment for: Acute Lymphoblastic Leukemia

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

Development History and FDA Approval Process for Erwinaze

Dec 19, 2014Approval Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze
Nov 18, 2011Approval FDA Approves Erwinaze to Treat Acute Lymphoblastic Leukemia
Nov  9, 2010EUSA Pharma Submits Erwinase Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia

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