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J&J Hopes FDA Will Approve Old Drug Under New Name

The Food and Drug Administration is expected to reach a decision today on the marketing application for paliperidone, a once-a-day schizophrenia drug from Johnson & Johnson derived from its best-selling product, Risperdal. Its rebirth as paliperidone is the latest wrinkle in the quest by pharmaceutical companies to extend sales and profits from aging blockbusters whose patents are about to expire--they tweak and relaunch them under new names. Chemically, the new drugs are just different enough to win more patent life. But they offer scant medical advantages over their predecessors, despite costing much more than generic versions of the old hits, critics say. Generic Risperdal, or risperidone, could be available as soon as next year or 2008. J&J hasn't yet selected a marketing name for paliperidone, but it plans to market the new treatment as a significant improvement over Risperdal. The issue has broad implications as consumers, employers and government programs struggle to pay for rising prescription-drug bills. Some analysts have forecast sales for paliperidone as high as $2.5 billion in 2010. Risperdal had sales of $3.55 billion last year.



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