University of Minnesota PI Submits EUA Application to FDA for Fluvoxamine

University of Minnesota PI Submits EUA Application to FDA for Fluvoxamine

The University of Minnesota’s David Boulware went on the record that he went through the process of submitting an Emergency Use Authorization (EUA) application for fluvoxamine to the U.S. Food and Drug Administration (FDA).

While the  Professor of Medicine, Division of Infectious Diseases and International Medicine at the University of Minnesota recently discussed the promise of the Pfizer antiviral called PAXLOVID, he notes that the medicine isn’t available today and that the FDA has only authorized it for use by those classified as high-risk unvaccinated people or persons with weak immune systems. But there are so many other needs during this pandemic. 

He notes the third option in a University of Minnesota press release—fluvoxamine declaring that the SSRI “based on two randomized trials” offers a 30% reduction in hospitalization or lengthy emergency department visits. The academic medical center principal investigator declared, “On December 21, I submitted an application to the FDA requesting Emergency Use Authorization (EUA) to recognize its clinical benefit.” Boulware declared he hopes that his action will lead to a response by the regulatory body in the form …