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

Executive Summary

NDAC will discuss whether data supports oral phenylephrine’s GRASE as nasal decongestant. Potential for removing phenylephrine from monograph could be linked to restricting nonprescription pseudoephedrine drugs to behind-the-counter sales since 2006 and overhaul of FDA monograph program authorized in 2020.

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Two days after FDA advisory panel’s meeting to discuss whether oral phenylephrine is effective for nasal congestion, complaints filed in federal court in multiple states alleging manufacturers knowingly misled public about ingredient’s efficacy. FDA’s potential response to NDAC’S finding wouldn’t come as soon.

US Advisory Panel Leaves No Room For Doubt: Oral Phenylephrine Ineffective As Nasal Decongestant

Action on unanimous statement by Nonprescription Drug Advisory Committee could be one of FDA’s first in its more streamlined process for making OTC monograph changes. Regulatory change on phenylephrine available in US also could reach OTC and Rx drugs available through applications.

Oral Phenylephrine Study Results Spell Nasal Decongestion Failure To Critics, GRASE To Industry

FDA officials, joined by supporters of deeming ingredient non-GRASE, note problems with research referenced in initial GRASE designation. CHPA explained studies used to support GRASE designation for phenylephrine hydrochloride in 1976, for addition of bitartrate salt in 2006 and other results published since show ingredient’s efficacy for nasal decongestion.

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