Erectile dysfunction drugs haven’t generated the most noise as likely OTC switch candidates with the US Food and Drug Administration moving toward making digital labeling part of its regulatory framework to make more ingredients available nonprescription.
US FDA's ACNU Proposed Rule Played Petros Pharma’s Tune To Attempt OTC Switch Of ED Drug
For ED products, “where you have a contraindication for current use of nitrates, this enables you now to leverage technology to help assist the consumer without a physician intermediary to appropriately self-select. Yes, music to our ears, we loved it,” says president Fady Boctor.
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
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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.
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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.
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“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.
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Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
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Jump in cough & cold sales at the end of the year helps Recordati post higher OTC revenues for 2024.
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Italy's Alfasigma has expanded its operation in Germany with the creation of a new Consumer Healthcare unit. Led by Rüdiger Hoppe, the business is rolling out OTC medical devices and dietary supplements in the gastrointestinal category.