Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph

The authors of a citizen petition say researchers have met a bar FDA set for studies showing oral phenylephrine is not effective as a nasal decongestant and should be removed from the OTC monograph.

University of Florida pharmacy professors Leslie Hendeles and Randy Hatton ask the agency to issue a final rule removing oral PE from the final OTC monograph for cold, cough, allergy, bronchodilator, and antiasthmatic drug products and to remove PE bitartrate from the 2006 amendment to the monograph, according to a