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FDA's Pradaxa Quandary: Clearing Both Doses Could Mask Dabigatran's Superiority

Executive Summary

The pivotal issue remaining for FDA's review of Boehringer Ingelheim's Pradaxa (dabigatran) is whether it will clear both the 110 mg and 150 mg doses and how it can craft labeling to guide appropriate use toward the higher dose, which seems likely to gain a superiority claim over warfarin.

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