What's new in children's drugs

ABSTRACT

There have been major advancements in the treatment and prevention of COVID-19. [...]far, only remdesivir1 (Veklury) has received FDA approval for treatment of COVID-19 in adults and children 12 years and older, but its use in younger children is permitted only under an emergency use authorization (EUA). Morphine oral solution (2 mg/mL and 4 mg/mL) is now indicated for pediatric patients aged 2 to 17 years with acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate.8 Safety and efficacy in this age group are supported by extrapolation from clinical evidence in adults and supportive data from an open-label safety and pharmacokinetic study in pediatric patients aged 2 to 17 years with postoperative acute pain. The labeling has been expanded to include safety and effectiveness in pediatric patients aged 12 to 17 years, offering this population an alternative nonopioid pain medication.10,11 This indication was based on extrapolation of efficacy from studies in adult patients combined with pharmacokinetic and safety data from 2 open-label studies with a combined 49 patients aged 12 to 17 years and an activecontrolled study in 76 pediatric patients aged 12 to 16 years. Dalbavancin (Dalvance) is a unique glycopeptide antibiotic that is approved in all pediatric patients from birth.14 It is indicated for the treatment of acute bacterial skin and soft tissue infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.