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Fragmin approved by FDA as first anticoagulant for children

May 17, 2019 / Anna Smith

The US Food and Drug Administration has approved Pfizer’s Fragmin (dalteparin sodium) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in paediatric patients one month of age and older. The drug was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The FDA also granted this application Priority Review designation. The efficacy of Fragmin in children was based on a single trial with 38 paediatric patients with symptomatic deep vein thrombosis and pulmonary embolism who were were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.