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Physician Communication That Combined Results Of Unrelated Studies Gets Rebuke From US FDA

 
• By Brenda Sandburg

Althera’s misleading claims about its cholesterol drug Roszet is based on a ‘scientifically unsound analysis,’ OPDP tells company. FDA says studies cited in the pamphlet for doctors do not support claims regarding the magnitude of treatment effect.

Two studies
US FDA objects to Roszet drug promotion combining the results of two studies • Source: Shutterstock

Althera Pharmaceuticals Inc. touted the ability of Roszet (rosuvastatin/ezetimibe) to reduce LDL-C levels from 64% to 72% in a promotional sheet to doctors. But the US Food and Drug Administration objected to the calculations, which were derived from combining the results of two separate and unrelated studies.

The Office of Prescription Drug Promotion sent the company a 2 June untitled letter saying its claims about the...

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