• The U.S. FDA is proposing issuing an order that would remove the oral decongestant phenylephrine from many over-the-counter cough and cold medicines as a review has found the drug ineffective.
• The agency said that a comprehensive evaluation examined data from decades ago used to support oral phenylephrine's initial approval as well as newer data. Other formulations of phenylephrine are not impacted.
• Oral phenylephrine is found in many popular OTC cough and cold remedies including Kenvue's (NYSE:KVUE) Sudafed, Procter & Gamble's (PG) DayQuil and NyQuil, and Haleon's (NYSE:HLN) Robitussin and Triaminic.
• The FDA's proposed order is not a surprise considering an advisory committee in September 2023 voted that oral phenylephrine lacks effectiveness.
• The following month, CVS Health (CVS) pulled products containing oral phenylephrine from its shelves.

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