FDA approval for the intravenous administration of Erwinaze®


Jazz Pharmaceuticals report “Jazz Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

“Administration of Erwinaze through an intravenous infusion provides physicians another option for patients, including those who cannot tolerate intramuscular injections,” said Jeffrey Tobias, M.D., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals plc. “Gaining FDA approval of this expanded label for Erwinaze reflects our continued commitment to improving patients’ lives.”

Prior to this approval, the only approved route of administration for Erwinaze was through intramuscular injection. With the expanded label, the formulation of Erwinaze currently on the market may now be administered to patients by either intravenous infusion or intramuscular injection. The updated product label provides data and information to help physicians understand the different administration options and determine which route of administration is most appropriate for their patients.

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