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Drugs in the Pipeline

Pradaxa Under Review for DVT and PE

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).
News

GI Bleed Hospitalization Risk Linked to Oral Anticoagulant Choice, PPI Cotherapy

To compare the incidence of hospitalization for upper GI tract bleeding, researchers used US Medicare beneficiary files to identify a cohort of patients that were ≥30 years old who initiated oral anticoagulation therapy with apixaban, dabigatran, rivaroxaban, or warfarin, with or without PPI cotherapy.
Safety Alerts and Recalls, Uncategorized

Single Lot of Pradaxa 75mg Recalled

Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Drugs in the Pipeline

FDA Accepts sNDA for New Pradaxa Indication

Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.