WASHINGTON (Reuters Health) Mar 14 – Janssen Pharmaceutica, the drugmaking unit of Johnson & Johnson, said after market close on Wednesday that it has received a supplementary approval from the US Food and Drug Administration (FDA) to market its antipsychotic Risperdal (risperidone) for delaying relapse in the long-term treatment of schizophrenia.
The FDA initially approved Risperdal in 1994. The Titusville, New Jersey-based drugmaker said that the new indication would address the 20%-50% of patients who are rehospitalized every year due to a relapse.
The Johnson & Johnson subsidiary said that the expanded approval was based on results of a multicenter clinical trial demonstrating that Risperdal reduced the risk of relapse by 48%
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