FDA Approves Pfizer’s Fragmin Anticoagulant for Pediatrics

The FDA approved Pfizer’s 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.

• Richard Pazdur, director of FDA’s Oncology Center of Excellence and acting director of Office of Hematology and Oncology Products, says, “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients.”
• Labl for Fragmin contains a boxed warning to ...