"It is the FDA's role to ensure that drugs are safe and effective," said Patrizia Cavazzoni, emphasizing the agency's decision to propose the removal of oral phenylephrine due to its ineffectiveness as a nasal decongestant.
The slow-moving abandonment of phenylephrine has been years in the making, initially approved in 1976, becoming prevalent only after 2006 due to restrictions on pseudoephedrine.
The FDA's proposed order to remove oral phenylephrine will initiate a public comment period; if no deliberate objections arise, the removal will become final.
Critics have questioned phenylephrine’s effectiveness since a 2007 FDA panel reevaluation, which consistently indicated that the drug does not effectively relieve nasal congestion.
Collection
[
|
...
]