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Phenylephrine Efficacy Studies Inconclusive, FDA’s Monograph Division Says

This article was originally published in The Tan Sheet

Executive Summary

Studies originally used to support phenylephrine efficacy under the OTC cold/cough monograph were insufficient "to provide a convincing demonstration of effectiveness," according to briefing materials prepared by FDA researchers for a Dec. 14 meeting of the Nonprescription Drugs Advisory Committee

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FDA's Nonprescription Drugs Advisory Committee recommends additional studies on phenylephrine efficacy for treatment of nasal congestion, although members say current data support the efficacy of the OTC cough/cold ingredient

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FDA's Nonprescription Drugs Advisory Committee recommends additional studies on phenylephrine efficacy for treatment of nasal congestion, although members say current data support the efficacy of the OTC cough/cold ingredient

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