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Prilosec OTC launch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA clears AstraZeneca/Procter & Gamble's proton pump inhibitor omeprazole June 20 for over-the-counter treatment of frequent heartburn. The approval follows the sponsors' completion of a patient labeling comprehen-sion study requested by FDA in an Aug. 8, 2002 "approvable" letter. The firms expect to launch Prilosec OTC 20 mg tablets in the fal
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