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Fujisawa Prograf Risk Education Plan Requested By FDA Warning Letter

Executive Summary

Fujisawa will implement a Prograf risk education plan for physicians in response to FDA complaints that a journal ad for the organ rejection agent failed to present adequate risk information

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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, to sign up for a free trial.]...

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Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011




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