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5/12/2020

Fludarabine Injection

Products Affected - Description

    • Fludarabine intravenous, Pfizer, 50 mg, vial, 1 count, NDC 61703-0344-18
    • Fludarabine intravenous injection, Sagent, 25 mg/mL, 2 mL vial, 1 count, NDC 25021-0242-02
    • Fludarabine intravenous, Teva, 50 mg, vial, 1 count, NDC 45963-0309-55

Reason for the Shortage

    • Fresenius Kabi did not provide a reason for the shortage.
    • Leucadia has fludarabine available.
    • Pfizer is discontinuing 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 injection, Fresenius Kabi, 25 mg/mL, 2 mL vial, 1 count, NDC 63323-0192-02
    • Fludarabine intravenous, Leucadia Pharmaceuticals, 50 mg, vial, 1 count, NDC 24201-0237-01
    • Fludarabine intravenous injection, Teva, 25 mg/mL, 2 mL vial, 1 count, NDC 45963-0621-51

Estimated Resupply Dates

    • Pfizer has fludarabine lyophilized powder 50 mg vials available in limited supply. They are discontinuing the product once it is depleted.
    • Sagent has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of June 2020.
    • Teva has fludarabine lyophilized powder 50 mg vials on back order and the company estimates a release date of late-July 2020.

Updated

Updated May 12, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 17, 2019 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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