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