The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
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Three major updates were added to the prescribing information for Pradaxa capsules, an oral anticoagulant. One included a warning that discontinuing treatment puts patients at increased risk of stroke.
Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Boehringer Ingelheim announced that the Pradaxa (dabigatran etexilate mesylate capsules) prescribing information has been updated to affirm that Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin