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

 
• By Malcolm Spicer

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.

• Source: Shutterstock

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...

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