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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 ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the US Food and Drug Administration ...
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 ...
Actually, J&J came up with phenylephrine in the 70s, but nobody has bothered to use it until pseudoephedrine became restricted. From the link "In 1976, the FDA deemed a 10 milligram oral dose of phenylephrine safe and effective at relieving congestion, making it possible for companies to use the ingredient without conducting studies."
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 notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms.