Nexium approved for children

February 29, 2008

AstraZeneca's Nexium (esomeprazole magnesium) has received approval by the Food and Drug Administration (FDA) for the short-term treatment of gastroesophageal reflux disease in children ages 1 to 11.

AstraZeneca's Nexium (esomeprazole magnesium) has received approval by the Food and Drug Administration (FDA) for the short-term treatment of gastroesophageal reflux disease in children ages 1 to 11.

The approved dosage is 10 mg or 20 mg daily, in the form of a delayed-release capsule or a liquid. Pediatric patients 12 to 17 years of age can take 20 mg or 40 mg daily, which is already approved.

The FDA approved Nexium based upon safety and pharmacokinetic studies performed in pediatric patients, as well as the extrapolation of data from the results of studies in adults to the pediatric population.

Nexium belongs to a class of drugs known as proton-pump inhibitors (PPIs). PPIs help heal erosions in the lining of the esophagus (erosive esophagitis) by decreasing the amount of acid produced in the stomach.