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3/24/2023

Fludarabine Injection

Products Affected - Description

    • Fludarabine intravenous solution for injection, Fresenius Kabi, 25 mg/mL, 2 mL vial, 1 count, NDC 63323-0192-02
    • Fludarabine intravenous lyophilized powder for injection, Leucadia Pharmaceuticals, 50 mg, vial, 1 count, NDC 24201-0237-01
    • Fludarabine intravenous, Pfizer, 50 mg, vial, 1 count, NDC 61703-0344-18 - discontinued
    • Fludarabine intravenous solution for injection, Sagent, 25 mg/mL, 2 mL vial, 1 count, NDC 25021-0242-02
    • Fludarabine intravenous lyophilized powder for injection, Teva, 50 mg, vial, 1 count, NDC 45963-0309-55
    • Fludarabine intravenous solution for injection, Teva, 25 mg/mL, 2 mL vial, 1 count, NDC 45963-0621-51

Reason for the Shortage

    • Areva did not provide a reason for the shortage.
    • Fresenius Kabi has fludarabine injection on shortage due to increased demand.
    • Leucadia did not provide a reason for the shortage.
    • Pfizer discontinued fludarabine in August 2020. Their estimated market share was less than 1%.
    • Sagent has fludarabine on shortage due to manufacturing delays.
    • Teva did not provide a reason for the shortage.

Available Products

    • Fludarabine intravenous solution for injection, Areva, 25 mg/mL, 2 mL vial, 1 count, NDC 59923-0604-02

Estimated Resupply Dates

    • Areva has fludarabine 25 mg/mL 2 mL vials available for direct orders only.
    • Fresenius Kabi has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of mid- to late-April 2023. Emergency orders may be available for active patients. Call Fresenius Kabi customer service for information.
    • Leucadia has fludarabine lyophilized powder 50 mg vials temporarily unavailable and the company cannot estimate a release date.
    • Sagent has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of June 2023.
    • Teva has fludarabine 25 mg/mL 2 mL vials temporarily unavailable and the company cannot estimate a release date. The lyophilized powder 50 mg vials are on allocation.

Updated

Updated March 24, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 17, 2019 by Stephen Andrews, PharmD, BCPS, CPPS, Drug Information Specialist. © 2023, 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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