Johnson & Johnson submitted an NDA Nov. 29 for its Risperdal follow-on paliperidone extended-release, the firm said Nov. 30.

The submission gives the schizophrenia therapy a user fee date in late September 2006.

The timeline puts J&J on track to launch paliperidone ER in advance of generic competition for Risperdal (risperidone), which could lose exclusivity as early as mid-2008.

Paliperidone ER is a metabolite of risperidone and uses J&J's proprietary OROS controlled-release technology, gained through J&J's acquisition of Alza in 1999.

J&J conducted two Phase III clinical trials to support the NDA, one of which is ongoing (¹ Also see "J&J Antipsychotic Paliperidone ER Moves Into Phase III" - Pink Sheet, 13 April, 2004.).

The firm said it plans to present initial Phase III data at upcoming medical meetings.

J&amp;J Submits Paliperidone ER

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J&J Submits Paliperidone ER