Asking Advisors About Phenylephrine Efficacy May Portend FDA Taking Streamlined Monograph Steps
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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US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE
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.
Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph
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.
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.