The association said it is "disappointed in FDA's proposal to reverse its long-established view of oral PE (phenylephrine). For decades, people have relied on oral PE to relieve their nasal congestion. … PE is the only oral OTC decongestant available without purchase restrictions and is included in numerous OTC cough and cold medicines labeled with a decongestant claim. Consumers need options for self-care and freedom of choice."
FDA proposes end to decongestant element
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The Consumer Healthcare Products Association, a trade group representing drugmakers, objected to the vote and said previous trials and regulatory determinations supported oral phenylephrine, or “PE,” as safe and effective.
FDA panel says ingredient in popular oral decongestants is not effective
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