Higher dose pravastatin formulation approved by FDA

WASHINGTON (Reuters Health) – Bristol-Myers Squibb has received approval from the US Food and Drug Administration (FDA) to market a 80-mg dose of its cholesterol-lowering drug Pravachol (pravastatin sodium), the drugmaker reported late Tuesday.

Princeton, New Jersey-based Bristol-Myers said that the 80-mg dose was developed to provide physicians with an option for treating patients who require higher dose therapy.

Bristol-Myers noted that Pravachol is the only statin indicated to reduce the risk of first or second heart attacks and strokes in patients with elevated cholesterol or coronary heart disease. The firm also noted that Pravachol has been demonstrated to have fewer liver-related side effects than other statins.

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