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J&J submits Risperdal follow-on

Executive Summary

Johnson & Johnson submits NDA for paliperidone extended-release Nov. 29, giving 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 to Risperdal (risperidone), which could lose exclusivity as early as mid-2008. The agent is a metabolite of risperidone and uses J&J's proprietary OROS controlled-release technology, gained through the company's acquisition of Alza in 1999 (1"The Pink Sheet" April 19, 2004, p. 12)...

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