Producing generics of OTC drug brands isn't enough for Perrigo Co. PLC any longer as it targets bigger growth and expects to get there marketing branded drugs, including developing its own Rx-to-OTC switches.
Perrigo Pegs Growth To Initiating OTC Switches, Not Following Brands' NDAs
"A foundation of this business has been," says Perrigo's Americas consumer business chief, Jeffrey Needham, "we are a fast follower. That's been our traditional model. We can't afford to do that going forward." In addition to initiating moving ingredients from Rx to OTC, firm is developing "national better brand" versions of drugs already available OTC.
More from Rx-to-OTC Switch
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.
Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.
FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.
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Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.