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5/18/2023

Docetaxel Injection

Products Affected - Description

    • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 1 mL vial, NDC 16729-0267-63
    • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 4 mL vial, NDC 16729-0267-64
    • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 8 mL vial, NDC 16729-0267-65
    • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 1 mL vial, NDC 72485-0214-01
    • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 4 mL vial, NDC 72485-0215-04
    • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 8 mL vial, NDC 72485-0216-08
    • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 2 mL vial, NDC 43066-0001-01
    • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 16 mL vial, NDC 55150-0380-01
    • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 2 mL vial, NDC 55150-0378-01
    • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 8 mL vial, NDC 55150-0379-01
    • Docetaxel intravenous solution for injection, Hikma, 20 mg/mL, 1 mL vial, NDC 00143-9204-01
    • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 16 mL vial, NDC 50742-0463-16
    • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 2 mL vial, NDC 50742-0428-02
    • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 8 mL vial, NDC 50742-0431-08
    • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 16 mL vial, NDC 67457-0533-16
    • Docetaxel intravenous solution for injection, Mylan (Viatris), 20 mg/mL, 8 mL vial, NDC 67457-0781-08
    • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 16 mL vial, NDC 00409-0201-20
    • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 2 mL vial, NDC 00409-0201-02
    • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 8 mL vial, NDC 00409-0201-10
    • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 1 mL vial, NDC 00409-0366-01
    • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 4 mL vial, NDC 00409-0367-01
    • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 8 mL vial, NDC 00409-0368-01
    • Docetaxel intravenous solution for injection, Sagent, 20 mg/mL, 1 mL vial, NDC 25021-0245-01
    • Docetaxel intravenous solution for injection, Sagent, 20 mg/mL, 4 mL vial, NDC 25021-0245-04
    • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 16 mL vial, NDC 66758-0050-03
    • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 2 mL vial, NDC 66758-0050-01
    • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 8 mL vial, NDC 66758-0050-02
    • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 1 mL vial, NDC 47335-0323-40
    • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 4 mL vial, NDC 47335-0895-40
    • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 8 mL vial, NDC 47335-0939-40
    • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 1 mL vial, NDC 00955-1020-01
    • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 4 mL vial, NDC 00955-1021-04
    • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 8 mL vial, NDC 00955-1022-08
    • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 16 mL vial, NDC 70700-0176-22
    • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 2 mL vial, NDC 70700-0174-22
    • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 8 mL vial, NDC 70700-0175-22

Reason for the Shortage

    • Accord has docetaxel on manufacturing back order.
    • Armas did not provide a reason for the shortage.
    • Baxter has docetaxel injection on shortage due to increased demand.
    • Curae Pharma360 estimates a launch date in early third-quarter 2023.
    • Eugia did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Ingenus did not provide a reason for the shortage.
    • Meitheal has docetaxel injection available.
    • Pfizer has docetaxel injection on shortage due to increased demand.
    • Sagent did not provide a reason for the shortage.
    • Sandoz did not provide a reason for the shortage.
    • Sun Pharma did not provide a reason for the shortage.
    • Teva did not provide a reason for the shortage.
    • Viatris did not provide a reason for the shortage.
    • Winthrop did not provide a reason for the shortage.
    • Xiromed did not provide a reason for the shortage.

Available Products

    • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 16 mL vial, NDC 43066-0010-01
    • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 8 mL vial, NDC 43066-0006-01
    • Docetaxel intravenous solution for injection, Hikma, 20 mg/mL, 4 mL vial, NDC 00143-9205-01
    • Docetaxel intravenous solution for injection, Meitheal Pharmaceuticals, 10 mg/mL, 16 mL vial, NDC 71288-0144-16
    • Docetaxel intravenous solution for injection, Meitheal Pharmaceuticals, 10 mg/mL, 8 mL vial, NDC 71288-0144-08
    • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 2 mL vial, NDC 67457-0531-02
    • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 8 mL vial, NDC 67457-0532-08
    • Docetaxel intravenous solution for injection, Teva, 20 mg/mL, 1 mL vial, NDC 45963-0734-54
    • Docetaxel intravenous solution for injection, Teva, 20 mg/mL, 4 mL vial, NDC 45963-0765-52

Estimated Resupply Dates

    • Accord has docetaxel injection on back order and the company cannot estimate a release date.
    • Armas has docetaxel injection on back order and the company cannot estimate a release date.
    • Baxter has docetaxel 10 mg/mL 2 mL vials on back order and the company estimates a release date of October 2023.
    • Eugia has docetaxel 10 mg/mL 2 mL vials on long-term back order and the company cannot estimate a release date. The 10 mg/mL 8 mL and 16 mL vials are on intermittent back order and the company is releasing supplies as they become available.
    • Hikma has docetaxel 20 mg/mL 1 mL vials on back order and the company estimates a release date of late-May to early-June 2023.
    • Ingenus has docetaxel injection on back order and the company cannot estimate a release date.
    • Pfizer has docetaxel 10 mg/mL 8 mL and 16 mL vials available in limited supply. The 10 mg/mL 2 mL vials are on back order and the company estimates a release date of August 2023. The 20 mg/mL 4 mL vials are available in limited supply. The 20 mg/mL 1 mL and 8 mL vials are on back order and the company estimates a release date of August 2023 for the 1 mL vials and June 2023 for the 8 mL vials.
    • Sagent has docetaxel 20 mg/mL 1 mL and 4 mL vials on allocation. Check wholesalers for inventory.
    • Sandoz has docetaxel 10 mg/mL 2 mL and 16 mL vials on back order and the company estimates a release date of May 2023. The 8 mL vials are on back order and the company cannot estimate a release date.
    • Sun Pharm has docetaxel injection on back order and the company cannot estimate a release date.
    • Viatris has docetaxel 10 mg/mL 16 mL vials and 20 mg/mL 8 mL vials on back order and the company estimates a release date of late-June 2023.
    • Winthrop has docetaxel injection on back order and the company cannot estimate a release date.
    • Xiromed has docetaxel injection on long-term back order and the company cannot estimate a release date.

Updated

Updated May 18, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 27, 2023 by Leslie Jensen, PharmD, 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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