Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's Risperdal (Risperidone) oral solution, 1 mg/mL. Final approval is expected upon expiry of patent protection for the brand product on December 29, 2007.

Upon final approval, Teva's Risperidone oral solution will be the AA-rated generic equivalent of Risperdal oral solution, a product indicated for treatment of schizophrenia and acute manic or mixed episodes associated with Bipolar I Disorder, a company release said.

Annual brand product sales in the US were approximately $66 million for the twelve months ended June 2006, based on IMS data.