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FDA approves delayed-release Prilosec for toddlers

3/21/2008

WASHINGTON The Food and Drug Administration’s Division of Gastroenterology Products has approved AstraZeneca’s Prilosec delayed release oral suspension.

The drug is indicated for short-term treatment of symptomatic gastroesophageal reflux disease and healing of erosive esophagitis in pediatric patients 1 to 2 years old.

The division also released recommended daily doses for patients aged 1 to 16. If a patient weighs less than 22 lbs, then he or she should be given 5 mg; between 22 and 44 lbs, then administer 10 mg; and if greater than 44 lbs, 20 mg.

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