An advisory panel has answered in no uncertain terms the US Food and Drug Administration’s question on whether research supports the efficacy of one of the most commonly used OTC nasal decongestants, oral phenylephrine.
US Advisory Panel Leaves No Room For Doubt: Oral Phenylephrine Ineffective As Nasal Decongestant
Action on unanimous statement by Nonprescription Drug Advisory Committee could be one of FDA’s first in its more streamlined process for making OTC monograph changes. Regulatory change on phenylephrine available in US also could reach OTC and Rx drugs available through applications.