Premium
FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients
Author(s) -
Merino Margret,
Richardson Nicholas,
Reaman Gregory,
Ande Anusha,
Zvada Simbarashe,
Liu Chao,
Hariharan Sudharshan,
De Claro R. Angelo,
Farrell Ann,
Pazdur Richard
Publication year - 2020
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.28688
Subject(s) - medicine , venous thromboembolism , food and drug administration , dosing , intensive care medicine , surgery , thrombosis , pharmacology
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk of recurrence in pediatric patients 1 month of age and older. Approval was primarily based on FDA review of a single‐arm trial evaluating dalteparin administered subcutaneous twice daily in 38 pediatric patients with symptomatic VTE. Efficacy was based on the achievement of therapeutic plasma anti‐Xa levels. The FDA concluded that dalteparin has efficacy and acceptable safety for pediatric patients.