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The U.S. Food and Drug Administration has granted tentative approval for the Abbreviated New Drug Application submitted by Teva Pharmaceuticals (TEVA) to market its generic version of Risperdal® (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected on December 29, 2007, upon expiry of patent currently held by Janssen.

Risperdal is a drug indicated for the treatment of bipolar mania and schizophrenia, and is FDA approved for the treament of irritability associated with autism.

Source: Teva