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FDA Moves to Eliminate Ineffective Over-the-Counter Decongestant
In a significant development, the Food and Drug Administration (FDA) has initiated the process to withdraw oral doses of a widely used over-the-counter decongestant. This decision follows the agency’s conclusion from last year that these products do not effectively alleviate nasal congestion.
Proposed Removal of Oral Phenylephrine
The FDA has issued a proposed order aimed at removing oral phenylephrine from the list of substances permitted in over-the-counter medications, commonly referred to as the OTC monograph. If this proposal is finalized, manufacturers will be prohibited from including phenylephrine in their products intended for temporary relief of nasal congestion.
Ensuring Drug Safety and Efficacy
“The FDA is committed to ensuring that all medications are both safe and effective,” stated Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “After thoroughly reviewing existing data and aligning with recommendations from our advisory committee, we are advancing this proposal to eliminate oral phenylephrine due to its ineffectiveness as a nasal decongestant.”
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