Asking Advisors About Phenylephrine Efficacy May Portend FDA Taking Streamlined Monograph Steps

NDAC will discuss whether data supports oral phenylephrine’s GRASE as nasal decongestant. Potential for removing phenylephrine from monograph could be linked to restricting nonprescription pseudoephedrine drugs to behind-the-counter sales since 2006 and overhaul of FDA monograph program authorized in 2020.

Some OTC drugs available in the US under a monograph could be removed from the market or need reformulating as the Food and Drug Administration reconsiders the efficacy of oral phenylephrine as a nasal decongestant.

The potential for removing phenylephrine from a monograph could be linked both to nonprescription pseudoephedrine drugs being limited to behind-the-counter...