Docket No. FDA-2024-N-4734-0001: Amending Over-the-Counter Monograph M012
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
The undersigned individuals write in strong support of the Food and Drug Administration’s November 8, 2024, proposed order to remove the oral decongestant phenylephrine as a nasal decongestant active ingredient from OTC Monograph M012. Data provided to the agency and summarized in the FDA’s Briefing Document for the Nonprescription Drug Advisory Committee meeting on September 11-12, 2023, confirm that oral PE is barely absorbed into the bloodstream and that the best conducted clinical trials provide no evidence of efficacy on relevant clinical outcomes.
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