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GEN News Highlights : Oct 12, 2006

Teva Granted Tentative Approval for Generic Risperdal Oral Solution

Company will cut into the $66-million sales of the brand product.
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.