Nerivio Device Cleared for Migraine in Adolescents
The approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine.
The approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine.
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery.
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
Kineret blocks the biologic activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the IL-1 type I receptor.
The sBLA approval was based on data from a phase 3 study evaluating Xeomin in 216 patients aged 6 to 17 years with chronic sialorrhea associated with cerebral palsy, other genetic or congenital disorders, or traumatic brain injury.
The alert was based on data from three 20-week double-blind, placebo-controlled studies each with 34-week extensions.
Mucinex® Children’s FreeFrom™, a new line of over-the-counter cough and cold products free from artificial flavors, colors, and dyes, has been made available by Reckitt Benckiser.
Cough, rhinorrhea not predictive of positive test; anosmia/ageusia, nausea/vomiting, headache, fever were most predictive
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
Alkindi Sprinkle contains immediate-release oral hydrocortisone granules designed for the dosing needs of pediatric patients with adrenocortical insufficiency.