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PROCTER-SYNTEX' ALEVE RECOMMENDED DAILY DOSE SET AT 600 MG

This article was originally published in The Tan Sheet

Executive Summary

PROCTER-SYNTEX' ALEVE RECOMMENDED DAILY DOSE SET AT 600 MG to address concerns raised by FDA's Nonprescription Drugs and Arthritis Advisory Committees at a joint meeting in June that the proposed OTC dose for naproxen sodium was too close to the daily dose for prescription Anaprox and Naprosyn (naproxen). The advisory committees voted at the June meeting not to recommend approval of the switch due, in part, to questions about Syntex and P&G's proposed maximum daily dose of 800 mg and dosing interval of six-to-12 hours ("The Tan Sheet" June 7, 1993, pp. 1-6).
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