Pravachol is a drug indicated for patients with high cholesterol levels and those with increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke. Last year it was the 22nd highest-selling brand-name drug in the US.
Bristol-Myers Squibb's patent for the drug, however, ended recently, and the FDA has approved of the first generic vesion of the drug. Pravastatin Sodium Tablets (10mg, 20mg and 40mg) are manufactured by TEVA Pharmaceuticals.
Apotex Inc. earlier asked the U.S. Court of Appeals to block the FDA from approving Teva's application to sell pravastatin over a dispute about an exclusivity period for selling the drug. Despite this, according to the company's press release, TEVA has been granted 180 days of marketing exclusivity.
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