Bristol Pravachol Ads Broaden Indication, FDA Warning Letter Says
Executive Summary
FDA is asking Bristol-Myers Squibb to correct Pravachol advertising claims that the agency says broadens the indication and patient populations for which the cholesterol-lowering agent is approved
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Bristol Pravachol investigation
Bristol-Myers Squibb receives civil investigative demand from Missouri Attorney General relating to Pravachol DTC advertising from 2001-2003, 1Bristol's 10-K filing says. A separate, class action 2complaint filed in Kansas City, Mo. state court alleges the ads misled consumers "into purchasing Pravachol under the mistaken belief that it would help prevent strokes in people with high cholesterol even if they did not have any history of heart disease." In an August 2003 warning letter, FDA said the ads falsely implied that pravastatin is approved for prevention of stroke in patients without coronary heart disease (3"The Pink Sheet" Aug. 11, 2003, p. 4). Bristol issued a corrective ad in February. [Editor's note: For more coverage, log on to 4"The Pink Sheet" DAILY. Visit our website, www.ThePinkSheetDAILY.com to sign up for a free trial.]...
Bristol Pravachol investigation
Bristol-Myers Squibb receives civil investigative demand from Missouri Attorney General relating to Pravachol DTC advertising from 2001-2003, 1Bristol's 10-K filing says. A separate, class action 2complaint filed in Kansas City, Mo. state court alleges the ads misled consumers "into purchasing Pravachol under the mistaken belief that it would help prevent strokes in people with high cholesterol even if they did not have any history of heart disease." In an August 2003 warning letter, FDA said the ads falsely implied that pravastatin is approved for prevention of stroke in patients without coronary heart disease (3"The Pink Sheet" Aug. 11, 2003, p. 4). Bristol issued a corrective ad in February. [Editor's note: For more coverage, log on to 4"The Pink Sheet" DAILY. Visit our website, www.ThePinkSheetDAILY.com to sign up for a free trial.]...
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