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Pradaxa Review Shows FDA Doubts About The Power Of REMS To Change Prescribing Practices

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s decision to approve the 150 mg strength of Boehringer Ingelheim GmbH’s antithrombotic Pradaxa (dabigatran), but not the 110 mg dose, reflects agency doubts about the ability of risk management tools to change prescriber behavior that is likely to result in inappropriate use of a less effective dose.
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