US Advisory Panel Leaves No Room For Doubt: Oral Phenylephrine Ineffective As Nasal Decongestant
Executive Summary
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.
You may also be interested in...
Message Clear For Xylitol Nasal Spray Firm Xlear: ‘Capitalize’ On FDA’s Oral Phenylephrine Doubts
“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.
Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program
“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.
Fast Start To Oral Phenylephrine Efficacy Complaints As US FDA Considers 'Any Action'
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.