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The FDA announced a proposal to remove oral phenylephrine, found in many popular OTC decongestants, from shelves. The reason for the ban is that the ingredient just isn’t effective, the FDA says.
The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer ...
On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
Oral phenylephrine is ... “It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, ...
The Food and Drug Administration (FDA) is proposing to remove from the market a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work. The move brings FDA ...
The FDA advisory committee’s decision last year was nonbinding — meaning the FDA itself makes the final call on whether oral phenylephrine is considered effective and whether it needs to be ...
The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as ...
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence ...