Generic Antidepressant Needs Additional Scientific Evidence Prior to COVID-19 Authorization

The U.S. FDA recently issued a 25-page Memorandum Explaining Basis for Declining Request for Emergency Use Authorization (EUA) of Fluvoxamine Maleate for use related to COVID-19.

On May 16, 2022, the FDA's memo stated 'based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization.'

Therefore, the FDA has 'determined that the criteria for issuance of a EUA are not met and is declining to issue a EUA covering fluvoxamine for the treatment of COVID-19 at this time.'

The applying researchers had proposed that the generic medication could benefit lower-income countries with less access to oral COVID-19 therapies, such as Paxlovid and Lagevrio.

These U.S. FDA authorized medicines are readily available to qualifying people at most pharmacies in the U.S.

Currently, fluvoxamine is FDA-approved for treating obsessions and compulsions in patients with mental disorders in children and adults.

Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Note: The FDA announcement was manually curated for mobile readership.