2025-09065Notice

FDA Revokes Emergency Kidney Drugs as COVID Era Fades

Published Date: 5/21/2025

Notice

Summary

The FDA has officially ended the emergency use permissions for certain kidney treatment products from Fresenius and Baxter as of January 16, 2025. This means these products can no longer be used under emergency rules, affecting hospitals and patients relying on them during COVID-19. The change helps ensure only fully approved treatments are used, with no extra costs announced.

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

Emergency Use Authorizations Revoked

On January 16, 2025, the FDA revoked the Emergency Use Authorizations for Fresenius Medical Care North America’s multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048) and Baxter Healthcare Corp.’s REGIOCIT (EUA 068). This means those products can no longer be used under emergency rules and the change affects hospitals and patients who were relying on them during the COVID-19 pandemic; the notice also states the change helps ensure only fully approved treatments are used and that no extra costs were announced.

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Key Dates

Effective Date
Published Date
1/16/2025
5/21/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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