Shots:

• The approval is based on the single study results assessing Fragmin (dalteparin sodium) in 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism aged ≥ 1mos. for up to 3mos.
• The study demonstrated that 21 patients achieved resolution of the qualifying VTE- 7 showed regression- 2 resulted in no changes- no experienced progression of VTE is observed
• Fragmin (dalteparin sodium- SC) is a low molecular weight heparin indicated to reduce the recurrence of VTE- approved for the same indication in adults in 1994 and has received FDA’s PR designation for treating VTE in children

Ref: US FDA | Image: Behance