FDAnews Drug Daily Bulletin

The FDA has approved AstraZeneca’s blockbuster drug Nexium for children ages 1–11 for the short-term treatment of gastroesophageal reflux disease. The agency also approved a 10-mg dose for delayed-release oral suspension for the same patient population.

The safety and tolerability of Nexium (esomeprazole magnesium) in this age group was established in a multicenter, randomized, double-blind, open-label, parallel-group study in patients with a history of the condition.

Based on study results, it was determined that patients weighing less than 44 pounds should receive a once-daily 10-mg dose and those weighing more than 44 pounds should receive a once-daily 10- or 20-mg dose for up to eight weeks, according to AstraZeneca.