WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion.
FDA said it made the proposal after an agency review of the available data determined that oral phenylephrine is not effective for this use.
FDA made it clear that companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant because this is only a proposed order. Only a final order will affect what products can be marketed.
FDA further clarified that the proposed order is based on effectiveness concerns, not on safety concerns.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. FDA noted that some products only contain oral phenylephrine as a single, active ingredient. Others contain oral phenylephrine and another active ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended.
Phenylephrine is also an ingredient in nasal sprays to treat congestion. The FDA's action is only related to orally administered phenylephrine and not the nasal spray form.
The FDA is seeking public comments on this proposed order.
The Administration said that if, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the FDA will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant.
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