FDA Approved Labeling For Invega Sustenna, Updated December 20, 2017, To Include Comparative Outcomes

The U.S. Food and Drug Administration (FDA) released this document on December 20, 2017. The document is updated approved labeling for INVEGA SUSTENNA, an injectable long-acting antipsychotic (paliperidone palmitate). The updated section is on pages 49-52; it describes the outcomes of a 15-month clinical trial that tested this medication against oral antipsychotics. The people enrolled in the trial all had schizophrenia and had been incarcerated one or more times in the two years before they joined the trial. The outcomes focused on time-to-relapse in terms of reincarceration or hospitalization. Time-to-relapse lasted twice . . .