- 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
Click here to read full press release/ article | Ref: US FDA | Image: Behance