FDA approves first anticoagulant for pediatric patients

The US Food and Drug Administration said on Thursday it has approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.

Processed under the Priority Review designation system, the approval was granted to US pharma giant Pfizer (NYSE: PFE), whose shares edged up 1.19% to $41.64 by close of trading yesterday.

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.