Study Stirs Doubts On Phenylephrine, Questions On Monograph Process
This article was originally published in The Tan Sheet
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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Nonprescription Drugs Advisory Committee will meet online 11-12 September to consider data regarding generally recognized as safe and effective status for oral phenylephrine as a nasal decongestant which have become available since FDA last examined ingredient.
Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.
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.