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

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

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