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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 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 ...
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.
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 ...
But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages ...