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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 ...
While the FDA has issued a proposal, it has yet to issue a final order, which would determine the future availability of products containing oral phenylephrine as a nasal decongestant.
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 ...
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.
In June 2024, the US Food and Drug Administration (FDA) approved Phenylpropanolamine Hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. [78] [79] [80] This is the first generic phenylpropanolamine hydrochloride chewable tablets ...
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 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 ...