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Prilosec Rx-to-OTC switch

Executive Summary

AstraZeneca/Proctor & Gamble's Prilosec (omeprazole) prescription to over-the-counter application for prevention of symptoms of frequent heartburn will be reviewed by FDA's Nonprescription Drugs and Gastrointestinal Drugs Advisory Committees June 21. The committees previously voted against a switch for episodic treatment of heartburn but left the prevention claim open (1"The Pink Sheet" Oct. 23, 2000, p. 24). The revised application is for once-daily 20 mg for 14 days. The meeting will be held at the Holiday Inn in Bethesda, Md. at 8 a.m. (Sign up for a webcast at 2FDAAdvisoryCommittee.com)...

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