Skip to main content Back to Top
Advertisement

9/11/2019

Bivalirudin Injection

Products Affected - Description

    • Bivalirudin lyophilized powder for injection, AuroMedics, 250 mg, vial, 10 count, NDC 55150-0210-10
    • Bivalirudin lyophilized powder for injection, Dr. Reddy's, 250 mg, vial, 10 count, NDC 55111-0652-37
    • Bivalirudin lyophilized powder for injection, Pfizer, 250 mg, vial, 10 count, NDC 00409-8300-10

Reason for the Shortage

    • Accord has temporarily discontinued bivalirudin.
    • Apotex has discontinued bivalirudin.
    • AuroMedics did not provide a reason for the shortage.
    • Baxter has 250 mg/50 mL bivalirudin premixed bags available. The company is not actively producing the 500 mg/100 mL bags due to low demand.
    • Dr. Reddy's did not provide a reason for the shortage.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has bivalirudin on shortage due to manufacturing delays.
    • Sandoz did not provide a reason for the shortage.

Available Products

    • Angiomax lyophilized powder for injection, Sandoz, 250 mg, vial, 10 count, NDC 65293-0001-01
    • Bivalirudin lyophilized powder for injection, Fresenius Kabi, 250 mg, vial, 10 count, NDC 63323-0562-10
    • Bivalirudin lyophilized powder for injection, Pfizer, 250 mg, ADD-Vantage vial, 10 count, NDC 00409-8300-15
    • Bivalirudin lyophilized powder for injection, Sandoz, 250 mg, vial, 10 count, NDC 00781-3158-95
    • Bivalirudin injection, Baxter, 250 mg/50 mL, premixed bag, 24 count, NDC 00338-9572-24

Estimated Resupply Dates

    • AuroMedics has bivalirudin 250 mg vials on allocation.
    • Dr. Reddy's has bivalirudin 250 mg vials on allocation.
    • Pfizer has bivalirudin 250 mg vials available in limited supply.

Updated

Updated September 11, 2019 by Megan Dryer, PharmD. Created June 4, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

« Back to Drug Shortage Product Bulletins