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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Pravastatin Sodium Tablets, 80 mg
JERUSALEM, Israel | January 17, 2008 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Pravastatin Sodium Tablets, 80 mg.
Teva's Pravastatin Sodium Tablets, 80 mg are the AB-rated generic equivalent of Bristol-Myers Squibb's Pravachol® 80 mg tablets, and are indicated for treatment of certain hyperlipidemias and the primary prevention of coronary events. Teva is already marketing the 10 mg, 20 mg and 40 mg strengths of this product.
Total annual sales of the 80 mg strength, including brand and generic sales, were approximately $173 million in the United States for the twelve months ended September 30, 2007, based on IMS sales 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. Over 80 percent of Teva's sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd.
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