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.
Tokyo-based Eisai has been granted marketing authorization approval in Japan for an OTC version of its Pariet-branded proton pump inhibitor for stomach pain, heartburn and bloating.
Join thousands of industry professionals who rely on HBW Insight for daily insights
Already a subscriber?
Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”
HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.
“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.
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.
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.
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.
