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