In Brief: CHPA Disagrees With FDA Warning; Adulterated Supplements Enforcement; DASCA Support Sought
This article was originally published in The Tan Sheet
FDA warns about painkillers for teething; enforcement against adulterated supplements; FDA warning letter for tainted bee pollen; Akorn must divest brands from Hi-Tech deal; senators seek support for DASCA; and consumer acetaminophen knowledge improves.
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Akorn’s $650 million acquisition of Hi-Tech Pharmacal provides a potential long-term platform for Rx-to-OTC switches and offers additional OTC cross-selling opportunities with retailers. Akorn CEO Raj Rai calls the transaction a “transformative event” that will be instantly accretive for the firm.
FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.
Concern that products with the painkiller benzocaine are linked to rare but serious and potentially fatal adverse events prompted an FDA consumer warning and could lead to label and package changes.