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7/9/2021

Asparaginase Erwinia chrysanthemi

Products Affected - Description

    • Erwinaze lyophilized powder for injection, Clinigen, 10,000 unit, vial, 1 count, NDC 57902-0249-01
    • Erwinaze lyophilized powder for injection, Clinigen, 10,000 unit, vial, 5 count, NDC 57902-0249-05

Reason for the Shortage

    • Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited (PBL), the sole manufacturer of Erwinaze. FDA is allowing temporary importation from PBL of Erwinase (crisantaspase) through Clinigen. The dosing substitution should be the same for Erwinase and Erwinaze.

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Clinigen Pharmaceuticals, in conjunction with FDA, is temporarily importing Erwinase, 10,000 unit vials in 5 count presentations from Porton Biopharma Limited (PBL). The temporary NDC is 81561-0413-05. More information can be found at https://www.fda.gov/media/149614/download. To place an order, contact McKesson Plasma and Biologics (MPB) directly at 1-877-625-2566

Alternative Agents & Management

    • Jazz is launching Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) in mid-July 2021.

Updated

Updated July 9, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 11, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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