Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced that the US Food and Drug Administration has granted final approval for the company’s abbreviated new drug application to market its generic version of Novartis’ antiepileptic therapy Trileptal (Oxcarbazepine) tablets, in dosages of 150 mg, 300 mg and 600 mg. Shipment of the product will begin in the near future.
The brand product had annual sales of approximately $690 million in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
Petah Tikva-based Teva is among the top twenty pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.
Shares in Teva closed at $45.39 in Nasdaq trading yesterday, near the top of its 52 week trading range of between $30.81 and $46.
Published by Globes [online], Israel business news - www.globes-online.com - on December 13, 2007
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