FDA Releases New Guidance on Oral Phenylephrine, Xlear Responds

On Nov. 7, the U.S. Food and Drug Administration (FDA) proposed removing oral phenylephrine from over the counter (OTC) medications due to “effectiveness concerns.” According to FDA, oral phenylephrine is widely used as an active ingredient in nasal decongestants. The agency conducted a comprehensive review of all available data on the safety and efficacy of ...