Invega — Risperdal’s “patent extender” falters in Europe

Invega has always held some interest for me as I was on Risperdal for about 14 years. Invega is a copycat drug made only so Janssen could have another drug available to charge exhorbitant prices after Risperdal went generic which happened in the middle of this year. I first read about Invega a long time ago on The Carlat Psychiatry Report.

The European Medicines Agency (EMEA) has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its application for an extension of indication for the centrally authorized medicine Invega (paliperidone) prolonged-release tablets.

Invega was expected to be used for the treatment of acute manic episodes associated with bipolar I disorder….

…In its official letter, the company stated that the withdrawal was based on the feedback from the early evaluation indicating that the data provided were not sufficient to support approval for this indication and the company’s view that it was not in a position to adequately address this issue at that time.

This sort of news is always encouraging, but we have to see what happens here in the US. I already know of people taking Invega for maintenance with bipolar disorder, as we all know off-label use of neuroleptics runs rampant.

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Invega — Risperdal’s “patent extender” falters in Europe

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