TEVA WINS TENTATIVE FDA APPROVAL FOR GENERIC RISPERDAL

Israel-based drugmaker Teva Pharmaceutical Industries announced that the FDA has granted tentative approval to the company's abbreviated new drug application 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 in 2007.

Upon final approval, Teva's drug 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.

Annual brand product sales in the U.S. were approximately $66 million for the 12 months ended June, the company said, citing IMS data.

Teva is among the top 20 pharmaceutical companies in the world and is a leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. More than 80 percent of Teva's sales are in North America and Europe.