Janssen withdraws EU application for Invega
Janssen-Cilag, a subsidiary of US health care major Johnson & Johnson, has withdrawn its application to extend the European indication for Invega (paliperidone) prolonged-release tablets to the treatment of acute manic episodes associated with bipolar I disorder.
In its official letter to the European Medicines Agency (EMEA), the company stated that the withdrawal was based on feedback from the early evaluation, suggesting that the data provided were not sufficient to support approval for this indication. The company took the view that it was not in a position to adequately address the issue. Invega was first authorized in Europe in June 2007 for the treatment of schizophrenia.
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