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Busulfan Injection

Products Affected - Description

    • Busulfan intravenous injection, Amneal, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 70121-1244-07 - discontinued
    • Busulfan intravenous injection, Armas Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 72485-0210-08
    • Busulfan intravenous injection, Fresenius Kabi, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 65219-0160-10 - discontinued

Reason for the Shortage

    • Amneal discontinued busulfan injection.
    • Armas Pharmaceuticals has temporarily discontinued busulfan injection.
    • Athenex is not currently marketing busulfan injection.
    • Fresenius Kabi discontinued busulfan in early-2022.
    • Meitheal Pharmaceuticals has busulfan available.
    • Pfizer has busulfan injection available.
    • Sagent has busulfan injection available.
    • Viatris has busulfan injection available.
    • Otsuka has Busulfex available.

Available Products

    • Busulfex intravenous injection, Otsuka America Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 59148-0070-91
    • Busulfan intravenous injection, Meitheal Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 71288-0116-11
    • Busulfan intravenous injection, Mylan (Viatris), 6 mg/mL, 10 mL single dose vial, 8 count, NDC 67457-0893-08
    • Busulfan intravenous injection, Pfizer, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 00409-1112-01
    • Busulfan intravenous injection, Sagent, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 25021-0241-10

Estimated Resupply Dates

    • Most marketed presentations are available.

Alternative Agents & Management

    • Consider evaluating the health-care system's total supply of busulfan before beginning patients on combination chemotherapy regimens containing busulfan. If adequate supplies are not available, select an alternative regimen.
    • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for busulfan.
    • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
    • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated.
    • Refer to national guidelines such as those from the National Comprehensive Cancer Network ( or American Society of Clinical Oncology ( for additional information regarding therapeutic use.


Updated April 29, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 4, 2019 by Stephen Andrews, PharmD, BCPS, CPPS, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.


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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