Cytisinicline, a plant-based alkaloid used as a smoking cessation ingredient available OTC in some Central and Eastern Europe countries, has shown strong results in two phase 3 studies by a US firm preparing to ask the Food and Drug Administration for approval as a new drug.
US Smoking Cessation Options Could Expand Behind Achieve Life’s Cytisinicline Studies
Achieved Life would seek approval as Rx smoking cessation drug, but ingredient has history of safety and efficacy available OTC in other countries, says lead researcher in study published in Journal of the American Medical Association.

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Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
HBW Insight catches up with Maxwellia CEO Anna Maxwell to discuss her company's journey so far, and what she sees as the opportunities for Rx-to-OTC switch in UK women's health and beyond.
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Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
A round-up of the latest consumer health industry appointments: GSCF elects chair; Kenvue hires Northern Europe head; Barentz names chief commercial officer.