Research & Development
Boehringer Ingelheim's Pradaxa oral pellets for children receive US FDA approval
22 June 2021 -

Germany-based Boehringer Ingelheim Pharmaceuticals Inc has received approval from the United States Food and Drug Administration (FDA) for its Pradaxa (dabigatran etexilate) oral pellets intended to treat children three months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins), directly after they have been treated with a blood thinner given by injection for around five days, it was reported on Monday.

The US FDA has also approved the product to prevent recurrent clots among patients three months to less than 12 years old who completed treatment for their first venous thromboembolism. The product was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for around five days, and to prevent recurrent clots in patients eight years and older who completed treatment for their first venous thromboembolism.

The product is the first US FDA-approved blood thinning medication that can be taken orally by children. It has received a priority review designation for this indication.

Login
Username:

Password:


Related Headlines