FDA to hold meeting on OTC oral nasal decongestant ingredients

October 25, 2007

FDA meeting on ingredients in OTC oral nasal decongestants.

In the Federal Register of Oct. 24, the FDA announced a meeting of a public advisory committee to discuss the safety and effectiveness of phenylephrine hydrochloride and phenylephrine bitartrate as OTC oral nasal decongestants. The meeting will be held on Dec. 14 from 8 A.M. to 5 P.M. The discussion at the meeting will address a citizen petition submitted to FDA on Feb. 1, which asserts that the available data do not support the adult and pediatric doses of phenylephrine hydrochloride and phenylephrine bitartrate that are generally recognized as safe and effective in the OTC drug monograph for cold, cough, allergy, bronchodilator, and antiasthmatic drug products. For more information, visit