Pradaxa™ (dabigatran etexilate) – New formulation approval, new indication
June 22, 2021 - The FDA announced the approval of Boehringer Ingelheim’s Pradaxa (dabigatran) oral pellets, for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.
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