Schizophrenia

FDA Approves INVEGA for Long-Term Maintenance Treatment of Schizophrenia

Published in Medical Letter on the CDC and FDA, May 20th, 2007

The U.S. Food and Drug Administration (FDA) today approved INVEGA(TM) (paliperidone) Extended-Release Tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia. INVEGA is now indicated for both acute (short-term) and maintenance (long-term) treatment of schizophrenia.

The agency's latest approval for INVEGA is based on a long-term efficacy study that demonstrated a significant benefit in delaying the time to relapse of symptoms of schizophrenia. This study ended early because efficacy was clearly demonstrated in a planned interim analysis. In addition, this study further supports the proven safety and tolerability...

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Source: Medical Letter on the CDC and FDA (2007-05-20)

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