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Erwinaze FDA Approval History

FDA Approved: Yes (First approved November 18, 2011)
Brand name: Erwinaze
Generic name: asparaginase Erwinia chrysanthemi
Dosage form: Injection
Company: Jazz Pharmaceuticals plc
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 timeline 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

Further information

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