In a long-sought move, the US Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant that the agency concluded last year is not effective at relieving stuffy noses.
Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drugmakers will no longer be able to include phenylephrine in products for the temporary relief of nasal congestion.
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research,