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news.The FDA has granted tentative approval for Teva Pharmaceuticals to market its generic version of Johnson & Johnson's Risperdal, indicated for the treatment of schizophrenia and bipolar disorder.
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Final approval is expected upon expiry of the product patent on December 29, 2007.
Upon final approval, Teva’s risperidone will be the AA-rated generic equivalent of Risperdal which is manufactured by Johnson & Johnsons Janssen LP.
Annual brand product sales in the US were approximately $66 million for the twelve months ended June 2006, according to Teva Pharmaceuticals.