June 12th 2023
If approved, nirsevimab would be the first immunization specifically to protect infants through their first RSV season. The Prescription Drug User Fee Act date is in the third quarter of 2023.
February 9th 2023
Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.
January 5th 2023
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
January 4th 2023
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
December 17th 2022
If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.
Gleevec (Imatinib) Novartis
Approved for pediatric chronic myeloid leukemia
Atomoxetine displays long-term efficacy in adult patients with ADHD
Long-term treatment of 384 adults ADHD patients with atomoxetine (Strattera, Lilly) showed that 67% responded with at least a 30% improvement and 40% had at least a 50% improvement.
New contraindications and precautions have been added to the labeling of methylphenidate HCl tablets (Ritalin and Ritalin-SR, Novartis)-approved for treatment of attention deficit/hyperactivity disorder (ADHD).
AccuNeb (Albuterol sulfate inhalation solution)
DuoNeb (Albuterol sulfate and ipratropium bromide inhalation solution) Dey
New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination
Epivir-HBV (Lamivudine tablets and oral solution) GlaxoSmithKline
New Indication: Hepatitis B indication expanded to pediatric patients
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