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OTC Prilosec For Chronic Use Needs Explicit Labeling, NDAC, GDAC Advise

This article was originally published in The Tan Sheet

Executive Summary

Chronic use of OTC Prilosec (omeprazole) may benefit patients with gastroesophageal reflux disease provided labeling explicitly lists appropriate warnings, advisory committee members concluded at a switch review for the heartburn drug.

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OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use

Prilosec 1 Switch For Heartburn Prevention, 14-Day Use To Be Considered

OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use

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