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Prilosec

This article was originally published in The Tan Sheet

Executive Summary

FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees will meet jointly Oct. 20 to consider AstraZeneca's NDA 21-229 to switch its blockbuster drug Prilosec (omeprazole) OTC; the nonprescription product would be distributed by Procter & Gamble. Proposed indications the committees will review are: "To relieve heartburn, acid indigestion and sour stomach" and "To prevent heartburn, acid indigestion and sour stomach brought on by consuming foods and beverages or associated with events such as stress, hectic lifestyle, lying down or exercise." On Oct. 19, NDAC will consider the safety of phenylpropanolamine, giving attention to a CHPA-sponsored Yale study on the risk of hemorrhagic stroke and PPA (1"The Tan Sheet" May 29, p. 11)

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