Amidst recent revelations regarding the declining efficacy of this prevalent decongestant, industry stakeholders are closely monitoring the FDA’s deliberations regarding the potential reclassification and withdrawal of phenylephrine in tablet form, from the market.

In this session, we will delve into the far-reaching implications these decisions may hold for the broader over-the-counter (OTC) market.

• Examining committee decisions and their potential influence on regulatory status changes
• Can the industry expect FDA to issue a proposed order removing it from the GRASE category?