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Haleon Gets Ahead Of FDA Phenylephrine Decision With Proactive Product Reformulations

 
• By Tom Gallen

Haleon has begun reformulating phenylephrine-containing oral decongestants marketed in the US as the company looks to get ahead of an anticipated FDA decision on the ingredient's use in OTC cough and cold products. The UK-based consumer health manufacturer revealed its plan as it reported organic sales up 3.5% in the first half of 2024.

A Theraflu product containing phenylephrine on sale in Los Angeles, CA in December 2023 • Source: Shutterstock

Haleon is proactively reformulating Robitussin, Theraflu and Advil cough and cold products as the US Food and Drug Administration weighs up whether to pull approval for oral phenylephrine as a nasal decongestant.

CEO Brian McNamara told Haleon’s earnings call that the company had decided to act after a US FDA advisory committee unanimously voted last year that oral phenylephrine at OTC monograph doses is ineffective to treat nasal congestion. The safety of oral phenylephrine at the recommended dose has not been called into question by FDA

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