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Prilosec OK for young children

This article was originally published in The Tan Sheet

Executive Summary

FDA approves AstraZeneca's Prilosec (omeprazole) for short-term treatment of symptomatic gastroesophageal reflux disease and erosive esophagitis in children 1 to 2 years old, the agency announced March 20. The label recommends 5 mg or 10 mg daily based on the child's weight. The approval comes less than a month after FDA approved AstraZeneca's proton pump inhibitor Nexium (esomeprazole) for short-term treatment in GERD patients 1 to 11 years old (1"The Tan Sheet" March 3, 2008, In Brief). Procter & Gamble already markets nonprescription omeprazole with Prilosec OTC and Schering-Plough this month filed a switch application with FDA for its PPI/antacid combination Zegerid (20 mg omeprazole/1100 mg sodium bicarbonate) (2"The Tan Sheet" March 17, 2008, In Brief)....

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