The United States Food and Drug Administration (FDA) has granted approval to United States-based Pfizer for the subcutaneous use of Fragmin (dalteparin sodium) injection intended for the treatment of potentially life-threatening blood clots in paediatric patients, it was reported on Friday.

The latest approval for the product is for the blood thinner to be used to decrease symptomatic venous thromboembolism in paediatric patients, aged one month and older.

Its efficacy in children was demonstrated in a single trial with 38 paediatric patients having symptomatic deep vein thrombosis and/or pulmonary embolism. In the trial, patients were subjected to the product for up to three months, with starting doses based on age and weight. After completion of the study, 21 patients achieved resolution of the qualifying venous thromboembolism, while seven patients had regression. Two patients did not show any change, while no patients had progression of the venous thromboembolism and one patient had recurrence of the condition.