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Medsafe Of New Zealand Cites U.S. FDA In Safety Defense Of Pradaxa

This article was originally published in PharmAsia News

Executive Summary

New Zealand's regulatory agency Medsafe sought to defend itself against safety questions raised over its approval of Boehringer Ingelheim's Pradaxa (dabigatran) for preventing blood clots in surgery by noting that it had access to the same clinical trial data required by U.S. FDA, which also approved the drug



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