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12/28/2021

Fludarabine Injection

Products Affected - Description

    • Fludarabine intravenous solution for injection, Areva, 25 mg/mL, 2 mL vial, 1 count, NDC 59923-0604-02
    • 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 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 available.
    • 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, Fresenius Kabi, 25 mg/mL, 2 mL vial, 1 count, NDC 63323-0192-02
    • Fludarabine intravenous lyophilized powder for injection, Teva, 50 mg, vial, 1 count, NDC 45963-0309-55

Estimated Resupply Dates

    • Areva has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of January 2022.
    • 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 April 2022.
    • Teva has fludarabine 25 mg/mL 2 mL vials temporarily unavailable and the company cannot estimate a release date.

Updated

Updated December 28, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 17, 2019 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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