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Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph

This article was originally published in The Tan Sheet

Executive Summary

A citizen petition says studies have answered the question FDA and advisory committee members asked in 2007, for studies on the most effective dose of PE as a nasal decongestant. The studies show “PE is no more effective than placebo,” the petition says.

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Study Stirs Doubts On Phenylephrine, Questions On Monograph Process

Researchers say “an optimal dose of PE that is safe and produces clinically significant decongestion is still unknown,” and advocates for removing phenylephrine from the OTC monograph say their study is the proof FDA requested.

Data Support Phenylephrine Efficacy, But More Studies Needed – NDAC

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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