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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.
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 ...
[13] [2] Phenylephrine has replaced pseudoephedrine in many over-the-counter oral decongestant products. [2] However, oral phenylephrine appears to be ineffective as a decongestant. [ 31 ] [ 32 ] In 2022, the combination with brompheniramine and dextromethorphan was the 265th most commonly prescribed medication in the United States, with more ...
The Food and Drug Administration (FDA) is proposing the removal from the market of a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work.
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
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 ...