12/22/2025

Andexanet Alpha Injection (Andexxa)

Products Affected - Description

- Andexxa intravenous lyophilized powder for injection, AstraZeneca, 200 mg, vial, NDC 00310-3200-04

Reason for the Shortage

- The Biologics License Application for Andexxa has been withdrawn effective December 22, 2025. AstraZeneca requested this withdrawal for commercial reasons, following discussions with the FDA. The decision was taken as alignment on a feasible path to convert Andexxa from conditional to traditional approval in the U.S. could not be reached. As agreed with the FDA, Andexxa will no longer be commercially sold by AstraZeneca in the U.S. after December 22, 2025. More information can be found at: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/update-safety-andexxa?utm_medium=email&utm_source=govdelivery

Available Products

- There are no presentations available

Estimated Resupply Dates

- Andexxa will no longer be distributed as of December 22, 2025.

Safety

- Product should not be used after December 22, 2025 since it will no longer be FDA approved.

Updated

Updated December 22, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created December 11, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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