J&J paliperidone NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Johnson & Johnson's Nov. 29 submission of the Risperdal (risperidone) follow-on paliperidone extended-release puts the firm on track to launch the schizophrenia treatment ahead of generic competition for Risperdal, which could lose exclusivity as early as mid-2008. The NDA is based on two Phase III trials, one of which is ongoing. Like risperidone, paliperidone is a dual dopamine D2 and serotonin 5-HT2 receptor antagonist...