The FDA is considering changing the regulatory status of oral phenylephrine, a key ingredient in nasal decongestants, due to concerns about its efficacy. If removed from guidelines, many over-the-counter cold and allergy products may be pulled from shelves. The FDA emphasized that the issue is based on lack of efficacy, not safety. This proposal comes after an FDA advisory committee found that current data does not support the ingredient’s effectiveness as a decongestant. The public can comment on the proposed order until May 7, 2025. In other regulatory news, various drugs received FDA approvals or faced setbacks, including a new Pfizer drug for hemophilia and Novavax’s updated Covid-19 vaccine.
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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market
