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FDA Approves First Blood Thinner for Children With VTE
Drugs Regulatory Affairs
The FDA gave the go-ahead for Pfizer’s Fragmin (dalteparin sodium), marking the agency’s first approval for an anticoagulant for pediatric patients.
Approved for adults in 1994, the drug is now also indicated for use in reducing the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month or older.
VTE usually occurs as a complication of conditions such as infection, cancer, congenital heart disease, trauma or surgery. It can cause blood clots in the deep veins of the leg or in the lungs.