Pradaxa Bleeding Events Prompt FDA To Revise Generic Bioequivalence Criteria
This article was originally published in The Pink Sheet Daily
Executive Summary
Revamped ANDA instructions – among new and revised draft guidance for 58 products announced by FDA – 'account for the fact that dabigatran exhibits large within-subject variability with respect to blood levels.'
You may also be interested in...
Boehringer Avoids Pradaxa Trial, Board Chair Deposition With $650 Mil. Settlement
Settlement expected to resolve approximately 4,000 Pradaxa personal injury claims.
Mini Sentinel Alleviates FDA Concern Over Pradaxa Bleeding Issue
Data from the pilot program a “driving factor” in the agency’s decision against changing its recommendations for the blood thinner following reports of increased serious bleeding events.
Pradaxa Bleeding Deaths Spur FDA Concerns, European Label Changes
FDA is investigating reports that more patients are experiencing serious bleeding events after taking Boehringer Ingelheim GmbH’s Pradaxa (dabigatran) than anticipated based on clinical trial results.