FDA approves dabigatran etexilate oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism
Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE.
Source:
US Food and Drug Administration
SPS commentary:
In November 2020, the European CHMP recommended paediatric license extension and paediatric formulations of dabigatran for treatment of VTE and prevention of recurrent VTE from birth to <18 years of age, supported by a new pharmaceutical form and strength (coated granules, 20mg, 30mg, 40mg, 50mg, 110mg, 150mg) and oral solution (6.25 mg/ml).