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Teva gets US FDA approval for carvedilol tabs
Jerusalem, Israel | Saturday, September 8, 2007, 08:00 Hrs  [IST]

Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its Generic version of GlaxoSmithKline's cardiovascular agent coreg (Carvedilol) tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg. Shipment of this product will begin immediately.

The brand product had annual sales of approximately $1.7 billion in the United States for the twelve months ended June 30, 2007, based on IMS sales data.

The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 76 per cent of Teva's sales are in North America and Europe.

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