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# FDA Rejects EUA for Fluvoxamine in Covid
- URL: https://www.fdaweb.com/fda-rejects-eua-for-fluvoxamine-in-covid/
- Published: 2022-05-16T12:00:00.000Z
- Updated: 2026-09-14T17:44:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151824

FDA has rejected an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician **David Boulware** and other researchers to allow the use of generic drug fluvoxamine maleate for outpatient treatment of Covid-infected adults to prevent progression to severe disease or hospitalization. Fluvoxamine is currently FDA-approved for treating obsessive compulsive disorder in children aged eight to 17 years and adults.

In an unusual [FDA release](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/nda/2020/EUA%20110%20Fluvoxamine%20Decisional%20Memo%5FRedacted.pdf?ref=fdaweb.com), a review summary notes that reviewers were concerned about data from a study Boulware submitted that gave as its primary endpoint the reduction of emergency department visits lasting more than six hours because it was not apparent that this represented a clinically meaningful threshold.

FDA also said fluvoxamine’s treatment benefit was “not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths. The STOP COVID and real-world data studies had design limitations, including small size, single center, endpoint selection, and lack of randomization.” And it says two additional trials, STOP COVID 2 and COVID-OUT failed to demonstrate a drug benefit in adults with mild COVID-19 in the outpatient setting, and both were stopped early due to futility.