Teva Pharmaceutical Industries received tentative approval in response to the abbreviated new drug application filed to market the company’s generic version of Janssen’s Risperdal® (Risperidone) Oral Solution, 1 mg/mL. Final approval is expected upon expiry of Risperdal’s patent on December 29, 2007.
Upon final approval, Teva’s Risperidone Oral Solution will be the AA-rated generic equivalent of Risperdal, indicated for treatment of schizophrenia and acute manic or mixed episodes associated with bipolar I disorder.
Annual brand product sales in the U.S. were approximately $66 million for the 12-month period, which ended on June 2006, based on IMS data, reports Teva.