Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Esketamine for the Treatment of Treatment-Resistant Depression

February 27, 2019

View as PDF

Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.

March 1, 2019, FDA response letter.


RSVP to Public Citizen's Gala

The event will feature a keynote address from U.S. Senator Sheldon Whitehouse and remarks from Desmond Meade — who led the campaign that restored voting rights to 1.4 million Floridians.