Fast Start To Oral Phenylephrine Efficacy Complaints As US FDA Considers 'Any Action'
Class Action Complaints Don’t Wait For Potential Action On Oral Phenylephrine By US FDA
Two days after FDA advisory panel’s meeting to discuss whether oral phenylephrine is effective for nasal congestion, complaints filed in federal court in multiple states alleging manufacturers knowingly misled public about ingredient’s efficacy. FDA’s potential response to NDAC’S finding wouldn’t come as soon.
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“Pharmaceuticals have their place, and many do wonderful things for health, but the science of nasal hygiene is clear,” says marketing director Joel Melton.
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.
Phenylephrine doesn’t meet efficacy bar within “generally regarded as safe and effective” standard for OTC monograph drugs, agency says in briefing prepared for NDAC meeting on 11-12 September. FDA say it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status of oral PE.”