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Study Stirs Doubts On Phenylephrine, Questions On Monograph Process

This article was originally published in The Tan Sheet

Executive Summary

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.

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US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE

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Asking Advisors About Phenylephrine Efficacy May Portend FDA Taking Streamlined Monograph Steps

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