Teva Announces Tentative Approval For Generic Risperdal (Reg) Oral Solution

Main Category: Schizophrenia
Also Included In: Bipolar;  Depression
Article Date: 15 Oct 2006 - 0:00 PDT

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. 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.

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

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd
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