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.
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...
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
