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7/19/2022

Argatroban Injection

Products Affected - Description

    • Argatroban intravenous injection, Fresenius Kabi, 100 mg/mL, 2.5 mL vial, 1 count, NDC 63323-0526-03
    • Argatroban intravenous injection, Hikma, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00143-9674-01
    • Argatroban intravenous injection, Mylan Institutional, 100 mg/mL, 2.5 mL vial, 1 count, NDC 67457-0212-02
    • Argatroban intravenous injection, Novartis, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00078-0930-61 - discontinued
    • Argatroban intravenous injection, Pfizer, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00409-1140-01
    • Argatroban intravenous injection, Sagent, 1 mg/mL, 50 mL vial, 1 count, NDC 25021-0414-50

Reason for the Shortage

    • AuroMedics did not provide a reason for the shortage.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Mylan Institutional did not provide a reason for the shortage.
    • Novartis discontinued argatroban.
    • Par has argatroban available.
    • Pfizer has argatroban on shortage due to increased demand.
    • Sagent did not provide a reason for the shortage.
    • Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019. Sandoz discontinued argatroban 1 mg/mL 125 mL vials in April 2020.
    • Teva is not marketing argatroban.

Available Products

    • Argatroban intravenous injection, AuroMedics, 1 mg/mL, 50 mL vial, 10 count, NDC 55150-0241-10
    • Argatroban intravenous injection, Hikma, 1 mg/mL, 50 mL vial, 1 count, NDC 00143-9559-01
    • Argatroban intravenous injection, Par Pharmaceuticals, 100 mg/mL, 2.5 mL vial, 1 count, NDC 42023-0182-01

Estimated Resupply Dates

    • Fresenius Kabi has argatroban 100 mg/mL 2.5 mL vials on back order and the company cannot estimate a release date.
    • Hikma has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release date of early- to mid-August 2022.
    • Mylan Institutional has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release date of mid- to late-September 2022.
    • Pfizer has argatroban 100 mg/mL 2.5 mL vials available in limited supply.
    • Sagent has argatroban 1 mg/mL 50 mL vials on limited allocation.

Updated

Updated July 19, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 20, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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